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Cardiovascular Research Unit
Clinical Trials and Registries
ISCHEMIC HEART DISEASE AND MYOCARDIAL INFARCTION
CRISP AMI
A Multi-Center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading with Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction
Principal Investigator
David Shavelle, M.D.
Study Coordinators
Karen Adams
Stephanie Mullin, R.N.
Heart attacks are usually caused by blood clots that block the flow of blood to the heart. Restoring blood flow through the blocked artery improves heart function and prolongs life in many people who are having a heart attack. People having heart attacks that experience pump failure (heart damage) often have complications due to low blood pressure and weakened heart muscle that increase the risk of prolonged hospitalization and recovery period, as well as death.
Some hospitals use a machine called an Intra-Aortic Balloon Pump (IABP) routinely to help patients who are having a heart attack with low blood pressure or pump failure (poor heart pumping function). The IABP helps to lessen the workload of the heart and increases blood flow to the heart and the rest of the body. The IABP consists of a balloon attached to the end of a catheter that is inserted into the aorta, which is the main artery that carries blood from the heart to the rest of the body. The balloon is inflated and deflated before and after each heartbeat by the IABP to assist the heart as it pumps blood through the body. The IABP is stopped and the balloon is removed once the heart has recovered with either the use of medication or a percutaneous coronary intervention (PCI) such as angioplasty or bypass surgery to open a blocked artery after the heart attack.
The purpose of the study is to examine whether putting the IABP in before the PCI procedure will reduce any damage to the heart muscle in people having a heart attack. The IABP has been cleared by the Food and Drug Administration (FDA) and used for over 20 years. It is the timing of when the IABP is used that is considered experimental and may be different from normal standard of care.
Enrollment Status: OPEN
SOLSTICE
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of 12 Weeks of Dosing with losmapimod and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects with Myocardial Infarction Without STsegment Elevation
Principal Investigator
David Shavelle, M.D.
Study Coordinators
Karen Adams
Stephanie Mullin, R.N.
Study Summary
This study is about an experimental drug called losmapimod. An “experimental drug” means it has not been approved by the U.S Food and Drug Administration (FDA).
The purpose of this study is to test how losmapimod will affect heart tissue as well as its effects on inflammatory markers after a heart attack. Losmapimod is not approved for doctors to prescribe to patients. It is first being studied by research doctors.
Enrollment Status: Pending IRB Approval
VIRGO
Variation in Recovery: Role of Gener on Outcomes of Young Acute Myocardial Infarction (AMI) patients, a 4-year project funded by the NHLBI
Principal Investigator
Vivian Mo, M.D.
Study Coordinators
Karen Adams
Stephanie Mullin, R.N.
Study Summary
This is a research study of men and women who are 55 years of age or younger, who have had heart attacks. The goal of this study is to help researchers and doctors better understand the period of time after a heart attack (recovery period) and to find out how certain things influence recovery from a heart attack such as heart attack symptoms (chest pain or angina, shortness of breath), daily functioning, and important relationships in life. This information will aid in the understanding of how these things affect recovery from a heart attack and if there are any differences in the recovery period between men and women.
Enrollment Status: OPEN
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