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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Eligible for invasive physiological assessment with adenosine and/or acetylcholine.
You will not qualify if you...
Hemodynamic instability.
Anticipated technical issues for physiology wire measurements.
Culprit vessel of acute coronary syndrome.
Contraindications for adenosine administration.
Contraindications for acetylcholine test.
Reduced life expectancy (less than 1 year).
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day procedure
Participants undergo invasive coronary physiological assessment including pressure-flow measurements and endothelial function tests using adenosine and acetylcholine to investigate coronary microcirculatory function and vasomotor disorders.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are followed up to 5 years to monitor clinical outcomes and symptoms through outpatient clinic visits or telephone contacts, including the Seattle Questionnaire of Angina.
Follow-up contacts at 30 days, 1 year, 2 years, and 5 years either in-person or by phone
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries.
Hernán Mejía-Rentería, Lin Wang, David Chipayo-Gonzales...