Treatment Trials

1,455 Clinical Trials for Various Conditions

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Effects of Remote Cardiac Ischemic Preconditioning
Description

A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that "preconditioning" has powerful protective effects. Through the observation of Jewish men wearing tefillin the investigators have discovered a method of bringing preconditioning to patients at risk for heart attacks. This study will focus on women as the majority of people who wear tefillin (and have been studied) are men.

Conditions

Cardiac Function and Preconditioning

A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Description

A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.

Conditions

Coronary; Ischemic

Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History
Description

This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.

Conditions

Air Pollution, Atherosclerosis

Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Description

This study seeks to expand the use of the NYU GeriKit mobile application ("app") in a diverse range of settings to better phenotype older patients, which will enhance both research and patient care.

Conditions

Ischemic Heart Disease

Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease
Description

The goal of this clinical trial is to test the effects of a drug (in the drug class called sodium-glucose cotransporter 2 inhibitors) in women who have symptoms of ischemic heart disease. The main questions the study aims to answer are: Does blood flow in the heart improve with study drug? Participants will be randomly assigned to a 12-week course of the study drug, dapagliflozin 10mg, or placebo. Blood flow in the heart will be assessed using stress cardiac magnetic resonance imaging at baseline and 12 weeks. The researchers will compare the results from the two groups.

Conditions

Myocardial Ischemia

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Description

This study is being done to observe the effects of treatment from a device called the Bioboosti which utilizes pulsed electromagnetic waves on its ability to improve blood flow to the heart tissue in individuals with coronary artery disease (CAD).

Conditions

Coronary Artery Disease, Myocardial Infarction

Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging
Description

To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.

Conditions

Ischemic Heart Disease

Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease
Description

Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability between normal successive heart beats, is a biomarker of both adaptive and maladaptive reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is associated with poor mental health outcomes in persons with IHD. As stated by polyvagal theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in persons with IHD. Decreased PSS has been associated with hopelessness in patients with cancer, but this relationship has not been studied in IHD beyond the applicant's small pilot study of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness about the future, is present in 27-52% of patients with IHD. This is of grave concern, because hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial infarction in patients with IHD, independent of depression. This research focuses on understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-term goal of developing and testing novel interventions to reduce the adverse effects of hopelessness and improve health outcomes in patients with IHD. Participants for this cross-sectional study will be recruited while hospitalized for an IHD event. Participants will include patients who report moderate to severe hopelessness from the sponsor's NIH-funded study (n = 225); additional patients with minimal to no hopelessness will be recruited and enrolled by the applicant (n = 45). Data collection will take place remotely two weeks after hospital discharge. Specific aims include: Aim 1) Evaluate the relationship between HRV and hopelessness in patients with IHD; Aim 2) Determine the relationship between PSS and hopelessness in patients with IHD; and Aim 3) Explore the possible mediating effect of HRV on the relationship between PSS and hopelessness in patients with IHD.

Conditions

Ischemic Heart Disease

Improving Wellbeing in Ischemic Heart Disease
Description

The purpose of this research is to see if Heart Health Yoga (HHY) Program when added on to standard cardiac rehabilitation (CR) will improve overall wellbeing and quality of life for patients experiencing ischemic heart disease, heart problems caused by narrowed heart arteries.

Conditions

Ischemic Heart Disease

The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
Description

DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

Conditions

Coronary Artery Disease, Myocardial Ischemia

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects with Symptomatic Ischemic Heart Disease. (ACESO-IHD)
Description

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Conditions

Diabetes Mellitus, Ischemic Heart Disease

Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
Description

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

Conditions

Left Ventricular Dysfunction, Coronary Artery Disease

Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease
Description

A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC).

Conditions

Heart Diseases

Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
Description

RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Conditions

Ischemic Heart Disease

Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Description

The purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). The investigators hypothesize that, compared to the TAU group, participants receiving the intervention will 1) experience greater confidence in managing their cardiac disease, as indicated by perceived self-efficacy and illness perceptions; 2) experience greater psychological adjustment as indicated by depressive, anxious, and demoralization symptoms; 3) experience greater engagement in health behaviors including healthy eating and physical activity.

Conditions

Coronary Artery Disease, Ischemic Heart Disease, Coronary Heart Disease

Dynamic Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease
Description

Coronary artery computed tomographic angiography (CTA) is a widely used, highly accurate technique for the detection of coronary artery disease (CAD), with sensitivity and negative predictive values of over 90% (1-4). Patients with normal CTA findings have an excellent prognosis and do not require further testing for CAD (5). However, like invasive coronary angiography (QCA), CTA is an anatomic test and, unless lesions are very severe (\>90% stenosis), cannot reliably predict the impairment of flow (functional significance) of intermediate grade stenoses. For this reason, in approximately 15-25% of patients, additional functional testing may be required after CTA, usually in the form of stress testing (6-8). Stress testing is commonly done by exercise or pharmacologic stress with electrocardiographic monitoring and often, imaging of myocardial perfusion by nuclear scintigraphy (MPI) or detection of abnormal contraction by echocardiography. This requires a separate procedure, entailing time, expense and limited risk. Furthermore, in patients with previously known CAD, CTA alone is not an adequate test, because in most cases there are multiple lesions that are possible sources of ischemia. Over the last 10 years, these investigators and others around the world have developed a method of imaging myocardial perfusion by CT (CTP). This test is an adjunct to the usual Cardiac Computed Tomography Angiography (CCTA) procedure and can be done immediately thereafter, using conventional pharmacologic stress agents. It has demonstrated accuracy in many single center trials, and in this large multicenter study, the CORE320 trial (9,10) which showed a high accuracy in predicting the combined results of QCA plus MPI testing and a second multicenter trial established non-inferiority of myocardial CTP compared with nuclear stress testing (11,12). Additionally, this investigator group has published a direct comparison of diagnostic performance of myocardial CTP imaging and SPECT myocardial perfusion imaging and demonstrated superior diagnostic performance of CTP imaging compared with SPECT for the diagnosis of significant disease on invasive angiography (13). CTP images can be acquired with two different approaches: static or dynamic. In the CORE320 study, the CTP protocol used static acquisition method. The static CTP method, samples a snapshot of the iodine distribution in the blood pool and the myocardium over a short period of time, targeting either the upslope or the peak of contrast bolus. The notion behind this is that, at the upslope of the contrast, the difference in attenuation value of the ischemic and remote myocardium is at the maximum which enables for qualitative and semi-quantitative assessment of myocardial perfusion defects. The static CTP, however, does not allow for direct quantification of the myocardial blood flow (MBF). One of the drawbacks of static CTP lies in the acquirement of only one sample of data and the possibility of mistiming of the contrast bolus that results in poor contrast-to-tissue ratios by missing the peak attenuation (14). Output and flow rate of the contrast material may affect bolus timing. In addition, the acquisition of data from sequential heartbeats affects the attenuation gradient and may result in a heterogeneous iodine distribution, mimicking perfusion defects (15). Furthermore, the static CTP is limited in detection of balanced ischemia, where the perfusion of the entire myocardium is impaired and therefore there is no reference remote myocardium for comparison for semi-quantitative or qualitative static methods of CTP interpretation. Dynamic CT perfusion imaging uses serial imaging over time to record the kinetics of iodinated contrast in the arterial blood pool and myocardium. This technique allows for multiple sampling of the myocardium and the blood pool and creating time attenuation curves (TAC) by measuring the change in CT attenuation over time. Mathematical modelling of TACs permits for direct quantification of MBF. Despite its advantages, the use of dynamic CTP were limited in the past. A high temporal resolution and high number of detectors are required for dynamic CTP to allow for entire myocardial coverage, and in order to obtain multiple consecutive images at high heart rates(16,17). But the main challenge of dynamic CTP acquisition was the high radiation dose associated with this technique. Nevertheless, with the introduction of the cutting-edge 320 detector CT scanning systems with fast gantry rotation the issue of the cardiac coverage is eliminated(17). The second-generation 320-row scanners also permit the quantification of the MBF with dynamic CTP acquisition with relatively low-dose of radiation(18,19). In this study the investigators aim to evaluate the feasibility, safety and accuracy of the low-radiation dose dynamic myocardial CT perfusion compared to static CTP approach to detect hemodynamically significant coronary artery disease.

Conditions

Coronary Artery Disease, Ischemia

Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
Description

This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

Conditions

Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis

Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease
Description

Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.

Conditions

Chronic Ischemic Heart Disease

Myocardial Ischemia and Transfusion
Description

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Conditions

Myocardial Infarction, Anemia

Heart Rate Variability as a Predictor of Ischemic Heart Disease
Description

Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

Conditions

Acute Coronary Syndrome

Stress Reduction Intervention for Women With Ischemic Heart Disease
Description

This is a single center, randomized controlled trial which will include women with ischemic heart disease to receive either a self-directed stress reduction program delivered through a smart-phone application or activity tracking only for the first month ("early SR intervention" and "delayed SR intervention", respectively). Patients will be monitored for 1 month for application use and step counts via telephone or email interview and/or collection of screen-captured data. Baseline questionnaires will be repeated at the end of one month to assess for all primary and secondary measures, at which time the control group (activity tracking only) will be introduced to the intervention program. The early SR intervention group will not receive a new intervention but will be encouraged to continue using the app. Data will be collected for an additional 2 months with all participants in both groups. After the three-month study period, the study will close with the collection of final questionnaire data.

Conditions

Ischemic Heart Disease

Cardiogoniometry for Detecting Coronary Artery Disease by CT Angiography
Description

Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG acquisitions. Vectorcardiography has a long tradition in cardiology for providing comprehensive information on myocardial function and integrity. In recent years, computer assisted analysis has allowed automated interpretation of vectorcardiography with promising results in comparison to standard ECG for identifying patients with coronary heart disease. This study aims to investigate the utility of cardiogoniometry for noninvasively identifying patients who are at risk from coronary heart disease.

Conditions

Coronary Heart Disease, Coronary Artery Disease, Ischemic Heart Disease

Ranolazine Mediated PVC Reduction in Ischemic Heart Disease
Description

The purpose of this study is to determine whether ranolazine has beneficial effects on cardiac ischemia through reduction of premature ventricular contraction burden.

Conditions

Ventricular Premature Complexes, Myocardial Ischemia

Chest Pain Perception and Capsaicin Sensitivity in Patients With Acute Cardiac Ischemia
Description

The purpose of this study is to determine whether there is a positive correlation between the ability to sense chest pain in the context of myocardial ischemia and the ability to sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active ingredient on hot chili peppers).

Conditions

Chest Pain

HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
Description

A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program. To validate the diagnostic performance of the HeartTrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using EST. Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis by the HeartTrends device for the detection of myocardial ischemia, as determined by stress echocardiography.

Conditions

Heart Rate Variability Ischemia Detection

Myocardial Ischemia Detection for Early Identification of Patients With Ischemic Chest Pain
Description

The purpose of this study is to evaluate whether new novel markers from the clinical electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can detect coronary artery disease in patients with chest pain. The researchers are especially interested in studying how changes in these unique waves evolve over time with rest and activity. It is hoped that the findings will be helpful in differentiating patients with cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early identification can accelerate treatment and save lives. Eligible participants are those age 18 and older who have been referred for a nuclear stress test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary artery disease as part of their clinical care.

Conditions

Cardiac Ischemia, Chest Pain, Shortness of Breath

Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Description

This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

Conditions

Myocardial Ischemia

Role of Stress Cardiac MRI in Predicting Adverse Clinical Events in Patients With Known or Suspected Ischemic Heart Disease
Description

The investigators plan to use retrospective data to assess heart function and structure abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests. The investigators are interested in how these MRI findings relate to long-term prognosis in people who are at risk for cardiac disease.

Conditions

Coronary Artery Disease

Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy
Description

Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS). Subsequent testing using these modalities will show improved oxygen to the heart muscle.

Conditions

Angina, Heart Disease

Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Description

This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.

Conditions

Myocardial Ischemia