Actively Recruiting

Age: 18Years +
All Genders
NCT05714319

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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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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