Testing coronary function in patients with non-obstructive artery issues
Intracoronary Provocative Test With Acetylcholine in Patients With Stable Myocardial Ischemia or Myocardial Infarction and Non-Obstructive Coronary Arteries: the "Provoke" Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05714319
This study is testing a special procedure to see if it can help understand heart problems in people who have chest pain or heart attacks but don’t have blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05714319 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of intracoronary provocative testing using acetylcholine in patients presenting with ischemia and myocardial infarction despite having non-obstructive coronary arteries. It aims to identify coronary vasomotor disorders that may contribute to these conditions, focusing on both epicardial and microvascular responses. The study will collect data and conduct clinical follow-ups to assess the effectiveness of this testing approach in diagnosing functional coronary alterations. By including both INOCA and MINOCA patients, it seeks to provide a more comprehensive understanding of these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with INOCA or MINOCA who are undergoing intracoronary provocative testing.
Not a fit: Patients with obstructive coronary artery disease or those not undergoing the specified provocative testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic strategies and treatment options for patients suffering from ischemic heart conditions with non-obstructive coronary arteries.
How similar studies have performed: Previous studies have shown success in using similar provocative testing approaches, particularly in patients with INOCA, but MINOCA patients have been less represented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * INOCA or MINOCA as clinical presentation. * Patient that underwent an intracoronary provocative test with ACh at the time of CAG, as suggested in current guidelines and consensus and according to clinical practice and medical choice and independently from the present study. * Patients with INOCA will be defined as those with a stable pattern of typical chest pain on exertion, at rest or both, without any sign of acute myocardial infarction (MI), and/or evidence of inducible myocardial ischemia undergoing a scheduled hospital admission for CAG. * Patients with MINOCA will be diagnosed based on clinical evidence of acute myocardial ischemia, detection of raise and fall of serum troponin T levels with at least one value exceeding the 99th percentile of a normal reference population and at least one of the following: 1) symptoms of myocardial ischemia (one or more episodes of chest pain at rest typical enough to suggest a cardiac ischemic origin in the previous 24 hours); 2) new ischemic ECG changes (ST-segment and/or T wave abnormalities); 3) development of pathological Q waves; 4) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic aetiology (19). * Written informed consent to participate. Exclusion Criteria: * Patient that did not undergo an intracoronary provocative test with ACh at the time of CAG. * Among patients presenting with suspected MINOCA, those with obvious causes of MI other than suspected coronary vasomotor abnormalities will be excluded (e.g.: Takotsubo syndrome, suspected diagnosis of myocarditis, pulmonary embolism, evidence of coronary thrombosis on an unstable plaque confirmed by optical coherence tomography, cardiotoxic drug administration, hypertensive crisis or severe valvulopathies).
Where this trial is running
Rome
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Rocco A Montone, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Rocco A Montone, MD, PhD
- Email: roccoantonio.montone@policlinicogemelli.it
- Phone: +39-0630154187
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.
Conditions: Myocardial Infarction With Non-Obstructive Coronary Artery, Ischemia With Non-Obstructive Coronary Artery, MINOCA, INOCA