29 Clinical Trials for Heart Attack (Myocardial Infarction)
The goal of this observational study to measure the heart's microvascular function in the setting of a myocardial infarction (MI), or heart attack, using a method called continuous saline thermodilution (CST). The participants will include people who are experiencing MI from sudden and complete blockage of a coronary artery requiring immediate balloon and/or stent therapy. After getting the balloon and/or stent therapy, participants will have their heart's microvascular system tested using CST. The main questions it aims to answer are: * What measurements using CST can we expect from the heart's microvascular system during a treated MI? * Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers? For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.
AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI). Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices.
This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 3 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.
This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.
The Women's HARP study is a multi-center study focusing on women with clinical presentation of myocardial infarction (MI). Women will complete stress questionnaires following presentation to the medical center with elevated cardiac enzymes and abnormal electrocardiograms (ECGs). 2 months following MI, participants will be screened for the Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported. After completing baseline assessments, participants will be randomized to Enhanced Usual Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.
The HARP study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with MINOCA (MI with Non Obstructive Coronary Arteries) to determine the underlying diagnosis in each participant. Participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.
The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.
The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI. Following a MI patients are at high risk of sudden cardiac death (SCD). The risk is highest in the first 40 days; however, current guidelines exclude patients from receiving an ICD during this time. This limitation is based largely on a single study, The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), which failed to demonstrate a benefit of early ICD implantation. However, this study was underpowered and used non-invasive tests to identify patients at high risk. EPS identifies patients with the substrate for re-entrant tachyarrhythmia, and has been found in multiple studies to predict patients at risk of SCD. Contrast-enhanced CMR is a non-invasive test without radiation exposure which can be used to assess left ventricular function. In addition, it provides information on myocardial viability, scar size and tissue heterogeneity. It has an emerging role as a predictor of mortality and spontaneous ventricular arrhythmia in patients with a previous MI. A total of 1,058 patients who are at high risk of SCD based on poor cardiac function (left ventricular ejection fraction (LVEF) ≤40%) following a ST-elevation or non-STE myocardial infarct will be enrolled in the trial. Patients will be randomised 1:1 to either the intervention or control arm. In the intervention arm all patients undergo early EPS. Patients with a positive study (inducible ventricular tachycardia cycle length ≥200ms) receive an ICD, while patients with a negative study (inducible ventricular fibrillation or no inducible VT) are discharged without an ICD, regardless of the LVEF. In the control arm patients are treated according to standard local practice. This involves early discharge and repeat assessment of cardiac function after 40 days or after 90 days following revascularisation (PCI or CABG). ICD implantation after 40 days according to current guidelines (LVEF≤30%, or ≤35% with New York Heart Association (NYHA) class II/III symptoms) could be considered, if part of local standard practice, however the ICD is not funded by the trial. A proportion of trial patients from both the intervention and control arms at \>48 hours following MI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. It will be used to simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury. The size of the infarct core, infarct gray zone (as a measure of tissue heterogeneity) and total infarct size will be quantified for each patient. All patients will be followed for 2 years with a combined primary endpoint of non-fatal arrhythmia and SCD. Non-fatal arrhythmia includes resuscitated cardiac arrest, sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) in participants without an ICD. Secondary endpoints will include all-cause mortality, non-sudden cardiovascular death, non-fatal repeat MI, heart failure and inappropriate ICD denial. Secondary endpoints for CMR correlation will include (1) the presence or absence of inducible VT at EP study, and (2) combined endpoint of appropriate ICD activation or SCD at follow up. It is anticipated that the intervention arm will reduce the primary endpoint as a result of prevention of a) early sudden cardiac deaths/cardiac arrest, and b) sudden cardiac death/cardiac arrest in patients with a LVEF of 31-40%. It is expected that the 2-year primary endpoint rate will be reduced from 6.7% in the control arm to 2.8% in the intervention arm with a relative risk reduction (RRR) of 68%. A two-group chi-squared test with a 0.05 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion of 0.028 experiencing the primary endpoint and a Group 2 proportion of 0.067 experiencing the primary endpoint when the sample size in each group is 470. Assuming 1% crossover and 10% loss to follow up the required sample size is 1,058 (n=529 patients per arm). To test the hypothesis that tissue heterogeneity at CMR predicts both inducible and spontaneous ventricular tachyarrhythmias will require a sample size of 400 patients to undergo CMR. It is anticipated that the use of EPS will select a group of patients who will benefit from an ICD soon after a MI. This has the potential to change clinical guidelines and save a large number of lives.
In order to define distinct and reliable arterial 18Fluorodeoxyglucose (FDG) thresholds identifying patients at risk for cardiovascular events, patients with a history of myocardial infarction will be included in this international multicenter trial. Non-enhanced whole-body FDG PET/CT will be performed in all patients and the arterial FDG uptake in the carotid arteries as well as the aorta will be quantified by calculating different uptake parameters. In addition, FDG uptake in hematopoietic tissues (spleen, bone marrow), visceral adipose tissue (VAT) and different brain regions (e. g. amygdala) will be measured. Furthermore, specific blood biomarkers including genetic biomarkers, which are linked to atherosclerotic disease with predictive power for future cardiovascular events, will be analyzed in a subgroup of patients. In part 2 of the trial, a 4-year follow-up period will be analyzed with a focus on the prediction of cardiovascular events (acute coronary syndrome, non-fatal ischemic stroke, ischemic cardiac death, other causes of death, coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure). The predictive value of the arterial, hematopoietic and cerebral FDG uptake parameters as well as of the specific blood and genetic biomarkers will be determined.
The aim of this study is to evaluate the impact of a Telehealth program on the time from First Medical Contact (FMC) to Reperfusion in STEMI (ST-elevation myocardial infarction) patients, by supporting local paramedics in their care delivery.
The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.
Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.
The goal of this clinical trial is to compare two types of exercise prescriptions in cardiac rehabilitation eligible older adults (60 years or older) with heart disease. The investigators found in a single site pilot trial (insert NCTxxx) that one exercise prescription was better and are now repeating this study in a larger population at two sites (Baystate Medical Center, Springfield MA and Henry Ford Health System, Detroit MI). The main questions the investigators aim to answer are: 1. Compare two different exercise prescriptions in cardiac rehabilitation on exercise outcomes 1. Graded exercise test +Target heart rate range prescription \[GXT-THRR\] 2. Rating of perceived exertion (RPE) 2. What is the role of psychological feedback on fitness outcomes during cardiac rehabilitation and physical activity outside of cardiac rehabilitation. 3. What are the long-term clinical outcomes between the two exercise prescriptions Participants will be asked to: * Complete surveys about physical activity, exercise anxiety, exercise efficacy, and fears about exercising * Perform fitness measures (6-minute walk test, balance tests, stand to sit tests, a 400 meter walk, and handgrip strength) * Attend at least 18 sessions of cardiac rehabilitation after they are randomized to their exercise prescription group * Wear a heart rate monitor and a physical activity monitor per study protocol Participants will be randomized (flip of a coin) to either receive a graded exercise test and psychoeducational feedback or lifestyle education (nutrition for cardiac). The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test and the lifestyle education group will use their ratings of perceived exertion for their exercise prescription.
COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.
The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.
The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.
Preclinical studies have demonstrated that high mechanical index (MI) impulses from a diagnostic ultrasound (DUS) transducer during an intravenous microbubble infusion (sonothrombolysis) can restore epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI). The investigators propose to demonstrate the clinical effectiveness of sonothrombolysis in multiple centers and in a wide scenario of acute coronary syndromes.
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
The purpose of this research is to determine if two proteins in the blood are increased during acute myocardial infarction and whether their levels are higher in those who develop heart failure than those who do not. These two proteins are produced and potentially released when the heart muscle is damaged. They may then be released into the blood and be detected by standard method in the research laboratory. At this time, detection of an increase in these proteins in the blood is not known to be associated with any disease or myocardial infarction.
The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.
BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services healthcare system. The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are: * Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care? * Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?
The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.
Patients post acute myocardial infarction (AMI) have a high risk of mortality but the use of an implantable defibrillator in the early aftermath of an AMI has not been shown to improve patients' survival. The VEST trial recently demonstrated an improved overall survival in post AMI patients with the use of a wearable defibrillator. The same improvement was not demonstrated for the risk of sudden cardiac death. Monitoring patients after AMI using an implantable cardiac monitor (ICM) may document findings that can impact patient management and eventually improve their outcomes. We are therefore conducting the AID MI trial to examine the impact of ICM on patient management in the post AMI setting.
A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy
The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.
The purpose of this research study is to discover the functions of circulating white blood cells, called monocytes, and associated circulating substances in heart attack and ischemic stroke patients. Ischemic Strokes (clots) occur as a result of an obstruction within a blood vessel supplying blood to the brain. A type of monocyte carrying a surface marker called "P2X4" helps the immune system sense and respond to danger signals from the body such as heart muscle and brain tissue injuries. The researchers expect to learn more about how these monocyte cells react to heart and brain tissue injury, and how the cells may then produce proteins or other chemical substances which promote the healing of heart muscle after heart attack and brain tissue after an ischemic stroke.
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies.
The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out, as defined by TOAST classification of subtypes of acute ischemic stroke. Aim 2: In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic.