31 Clinical Trials for Various Conditions
This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
The aim of this observational study is to evaluate the in hospital and 6 month outcomes of the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction in a large tertiary referral center. It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity matching this superiority remains.
This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.
Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).
The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.
The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.
The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
The objective of this study is to identify Acute Coronary Syndromes (ACS) patients' specific needs and preferences for depression treatment via in-person or virtual individual interviews to (a) guide MBCT adaptation; and identify barriers and facilitators to (b) group videoconferencing delivery, and (c) blood spot data collection to enhance feasibility. Through qualitative measures participants will report specific physical, cognitive, and behavioral symptoms to be targeted in the intervention, discuss barriers and facilitators to participating in a video-conference treatment program and completing blood spot data collection procedures.
The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart). The primary analysis will be designed as a multi-center, retrospective case-control study.
This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.
This study will determine the impact of Transcutaneous Vagus Stimulation(TVNS) and autonomic modulation of inflammation in patients admitted with " acute heart attack." After admission for "acute heart attack" or "myocardial infarction" patients will be randomized to either TVNS or placebo and their blood samples will be collected at different time points during admission and post discharge. Blood samples will be analyzed for various markers of inflammation.
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
This study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation myocardial infarction) and primary percutaneous coronary intervention.
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.
Percutaneous coronary intervention (PCI) for acute coronary syndromes frequently fails to restore myocardial perfusion despite establishing epicardial vessel patency. Endothelin-1 (ET-1) is a potent vasoconstrictor and its expression is increased in atherosclerotic coronary arteries. Our hypothesis is that increased activity of the endogenous endothelin system contributes to microvascular dysfunction, and adjunctive therapy with an endothelin receptor antagonist will result in improved microvascular blood flow. Aims: The aims of the study are to assess in patients with non ST-elevation myocardial infarction, whether: 1) PCI causes an increase in coronary blood ET-1 level; 2) an endothelin receptor antagonist acutely improves coronary microvascular blood flow following PCI. Non-ST segment elevation myocardial infarction (NSTEMI) is one type of heart attack. It is defined as the development of heart muscle necrosis results from an acute interruption of blood supply to a part of the heart which is demonstrated by an elevation of cardiac markers Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) in the blood and the absence of ST-segment elevation in ECG (electrocardiography). ST-segment is a portion of ECG, its elevation indicates full thickness damage of heart muscle. Absence of ST-segment elevation in NSTEMI indicates partial thickness damage of heart muscle occurs. Therefore, NSTEMI is less severe type of heart attack compared to STEMI (ST-segment elevation myocardial infarction) in which full thickness damage of heart muscle occurs.
The primary objective of the UPSTREAM Registry is to address the data gap regarding the course of NSTEMI (Non-ST-Elevation Myocardial Infarction)between ED (Emergency Department) arrival and diagnostic angiography in detail, by characterizing and following the ED and peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED treatment patterns and success of both ischemic and bleeding risk stratification prior to definition of the coronary anatomy, data generated via the UPSTREAM registry will allow plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet therapy in the management of NSTEMI. This registry further seeks to demonstrate that contemporary use of upstream ticagrelor is associated with an economically-sound utilization of hospital resources, and smooth transition of care into the outpatient, secondary prevention setting for the first 30 days after hospitalization. Finally, it will allow characterization of patient selection factors and processes for ticagrelor vs alternative OAP agents, carrying out that descriptive comparison through discharge. Patients transferred in to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent administration and diagnostic catheterization begin with ED care at the first hospital.
The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction (STEMI) patients. Microvascular obstruction (MVO) in cardiac magnetic resonance (CMR) is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention (PCI). Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO, previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission. Nevertheless, the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or thermodilution method. In this regard, the current study will evaluate the feasibility of functional angiography-derived IMR (angio-IMR) in the evaluation of MVO after successful primary PCI for STEMI.
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).