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ID04827498

Study of Myocardial Ischemia Without Blocked Coronary Arteries Using Invasive Pressure and Flow Tests and Endothelial Function Evaluation

Led by Hospital San Carlos, Madrid · Updated on 2021-04-26

600

Participants Needed

1

Research Sites

260 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying myocardial ischemia that occurs without blocked large coronary arteries, focusing on non-obstructive coronary artery disease causes such as microcirculatory dysfunction and vasomotor disorders. This prospective observational study aims to gain a deeper understanding of these conditions, their impact on symptoms and clinical outcomes, and to evaluate new assessment methods. The study is sponsored by Hospital San Carlos, Madrid, and involves patients referred for invasive coronary physiological tests. Participants undergo invasive coronary assessments using specialized wires that measure pressure, flow, and temperature during adenosine and acetylcholine testing. These tests evaluate both non-endothelium-dependent and endothelium-dependent coronary functions. The study follows criteria from the latest European expert consensus on Ischaemia with Non-Obstructive Coronary Arteries INOCA. Medical therapy is tailored based on test results, and safety of intracoronary testing is also documented. During the study, participants are monitored at 30 days, and 1, 2, and 5 years through clinic visits or phone calls. The Seattle Angina Questionnaire is used to track angina symptoms over time. Researchers measure patient and vessel-oriented composite outcomes for up to 5 years and patient symptom burden for up to 12 months. Secondary outcomes include incidences of death, myocardial infarction, revascularization, emergency visits, and safety during procedures, ensuring comprehensive long-term follow-up and data collection.

CONDITIONS

Brief Title

Myocardial Ischemia Without Obstructive Coronary Stenoses

Research Team

H

Hernan Mejia-Renteria, MD, PhD

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