Testing coronary function in patients with non-obstructive artery issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Advanced invasive diagnosis for post-PCI angina in patients referred for coronary angiography

  This study tests a specialized invasive approach to find the cause of angina in people who previously had PCI and are now referred for coronary angiography.

  Recruiting at 5 sites Fundacion Investigacion Interhospitalaria Cardiovascular · Leganés, Madrid and 4 other locations · NCT07638137

• Comparing coronary flow and microvascular measures before and after intracoronary nitroglycerin in people with angina and non-blocking coronary arteries

  This study will try whether giving a small dose of nitroglycerin inside the coronary artery changes blood-flow and microvascular measurements in adults with angina but no major blockages.

  Recruiting Baylor Research Institute · Plano, Texas · NCT06896903

• Assessing biomarkers and platelet function in patients with myocardial ischemia and non-obstructive coronary arteries

  This study is trying to find specific blood markers and how platelets work in people with heart pain caused by non-blocked arteries to help improve diagnosis and treatment options.

  Recruiting at 2 sites Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome and 1 other locations · NCT05714241

• Nitrate Beetroot Juice to Help Blood Flow in Women with ANOCA and CMD

  We’re testing whether nitrate-rich beetroot juice for 14 days can improve heart blood flow and quality of life for women with ANOCA and CMD compared with a placebo.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06948201

• Improving heart blood flow and angina in women using an SGLT2 pill (STRONG)

  This trial will test whether taking the SGLT2 pill Brezavvy for 12 weeks can improve coronary microvascular blood flow and reduce angina symptoms in women with non-obstructive coronary artery disease.

  Recruiting Phase 1 University of Virginia · Charlottesville, Virginia · NCT06600178

• Imaging for coronary microvascular dysfunction in patients with angina

  This study is testing a new way to use heart imaging to help people with chest pain and non-blocked arteries feel better and improve their quality of life.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT05634031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.