Actively Recruiting
Intracoronary Provocative Test With Acetylcholine in Patients With INOCA and MINOCA
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-26
600
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracoronary Provocative Test With Acetylcholine in Patients With INOCA and MINOCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical presentation of INOCA or MINOCA
- Underwent intracoronary provocative testing with acetylcholine during coronary angiography
- INOCA patients have stable typical chest pain without signs of acute myocardial infarction and/or inducible myocardial ischemia
- MINOCA diagnosis based on acute myocardial ischemia symptoms, troponin rise and fall, and evidence of ischemic ECG changes or imaging
- Provided written informed consent to participate
You will not qualify if you...
- Did not undergo intracoronary provocative testing with acetylcholine during coronary angiography
- For suspected MINOCA patients: presence of other clear causes of myocardial infarction such as Takotsubo syndrome, myocarditis, pulmonary embolism, coronary thrombosis confirmed by optical coherence tomography, cardiotoxic drugs, hypertensive crisis, or severe valvular heart disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
R
Rocco A Montone, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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