Understanding Myocardial Ischemia Without Blocked Arteries
Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
This study is trying to understand heart problems caused by non-blocked arteries in patients with chest pain to see how well different treatments work over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT04827498 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance knowledge about myocardial ischemia caused by non-obstructive coronary artery disease. It will enroll patients referred for coronary physiological assessment, utilizing pressure-flow measurements and acetylcholine tests to evaluate coronary hemodynamics. The study will diagnose microcirculatory dysfunction and vasomotor disorders based on established criteria and adjust medical therapy accordingly. Patients will be followed up over a period of five years to assess their angina status using the Seattle Questionnaire.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are eligible for invasive physiological assessments.
Not a fit: Patients with hemodynamic instability or contraindications for adenosine or acetylcholine tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients suffering from non-obstructive coronary artery disease.
How similar studies have performed: Other studies have shown promise in understanding non-obstructive coronary artery disease, but this specific approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent available. * Age ≥ 18 years. * Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine. Exclusion Criteria: * 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).
Where this trial is running
Madrid
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Hernan Mejia-Renteria, MD, PhD — Department of Cardiology, Hospital Clinico San Carlos
- Study coordinator: Hernan Mejia-Renteria, MD, PhD
- Email: hmejiarenteria@gmail.com
- Phone: +34 913303283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.