The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study

What this Trial Is About

Researchers are investigating whether symptoms like chest pain or shortness of breath are caused by heart problems, particularly reduced blood flow due to blockages or inflammation. The study aims to evaluate if detailed blood flow measurements from cardiac magnetic resonance imaging during stress can diagnose heart disease more accurately than standard methods. Early research suggests these detailed measurements may help doctors understand heart disease severity better. Participants will undergo a standardized cardiac magnetic resonance imaging protocol using Gadavist contrast and vasodilator stress with either regadenoson or adenosine. They will be randomly assigned to receive either standard qualitative imaging alone or both qualitative and quantitative imaging that produces detailed blood flow maps. Blood samples will also be collected for biomarker analysis. The study recruits patients with chest pain or abnormal ECG suspected of coronary artery disease across 20 U.S. sites over 1.5 years. Participants' demographics and imaging results are recorded at the start, with follow-up by phone or email at 3, 12, and 24 months to track medications, treatments, and adverse events. Medical records are reviewed to gather comprehensive follow-up data. The main outcome measured is a composite of major cardiovascular adverse events over 24 months, with additional monitoring of procedure-related complications and cost-effectiveness. Total participation lasts two years from the initial imaging.

The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study