NCT05714319Recruiting
Intracoronary Provocative Test With Acetylcholine in Patients With INOCA and MINOCA
Intracoronary Provocative Test With Acetylcholine in Patients With Stable Myocardial Ischemia or Myocardial Infarction and Non-Obstructive Coronary Arteries: the "Provoke" Study
Source: ClinicalTrials.gov · Last updated 26 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Coronary vasomotor disorders, occurring both at microvascular and epicardial level, have been demonstrated as responsible for myocardial ischemia in a sizeable group of patients undergoing coronary angiography (CAG), with clinical manifestations ranging from ischemia with non-obstructive coronary arteries (INOCA) to myocardial infarction with non-obstructive coronary arteries (MINOCA), along with life-threatening arrhythmias and sudden cardiac death. Intracoronary provocative testing with administration of acetylcholine (ACh) at the time of CAG may elicit epicardial coronary spasm or microvascular spasm in susceptible individuals, and therefore is assuming paramount importance for the diagnosis of functional coronary alterations in patients with suspected myocardial ischemia and non-obstructive coronary artery disease (CAD). However, previous studies mainly focused on patients with INOCA, whilst MINOCA patients were often underrepresented. Assessing the presence of coronary vasomotor disorders is of mainstay importance in order to implement the optimal management and improve clinical outcomes. Clinical predictors for a positive ACh test could allow the development of predictive models for a positive or negative response based on clinical and/or angiographic features readily available in the catheterization laboratories, thus helping clinicians in the diagnosis of coronary vasomotor disorders even in patients at high risk of complications.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 27 Jan 2023
- Start date
- 12 Jan 2023
- Primary completion date
- 12 Jun 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Coronary artery disease
- NCT number
- NCT05714319
What you commit to
- Study type: Observational
- Planned participants: 600
- From 12 Jan 2023 to the primary completion date, 12 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Patient that did not undergo an intracoronary provocative test with ACh at the time of CAG.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.