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Intracoronary Provocative Test With Acetylcholine in Patients With INOCA and MINOCA

NCT05714319 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-02-26

No results posted yet for this study

Summary

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

  • Myocardial Infarction With Non-Obstructive Coronary Artery
  • Ischemia With Non-Obstructive Coronary Artery

Interventions

OTHER

Data collection

Variables collected will include: * demographics (sex, age) * comorbidities (type 2 diabetes mellitus, familiar history of CAD, smoke habit, dyslipidaemia, hypertension, history of CAD) * echocardiographic (left ventricle ejection fraction at admission, the presence and grade of diastolic dysfunction, and the presence and grade of any valvulopathies) * angiographic data (presence of non-obstructive CAD (any coronary lesion \<50% diameter stenosis), the presence of myocardial bridge and, if this latter is present, its localization and length) * laboratory measurements (hematologic variables (haemoglobin and white blood cells), creatinine, high sensitivity cardiac troponin I (hs-cTnI), and C-reactive protein (CRP) at the time of admission) * medical therapy at admission * response to intracoronary provocative test with ACh.

OTHER

Clinical follow-up

All patients will undergo a clinical follow-up by telephonic interview and/or clinical visit at 6, 12, 24, 36, 48 and 60 months from hospital discharge, during which the incidence of MACCE in the past months will be investigated and collected.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Rocco A Montone, MD, PhD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2027-06-12
Completion
2028-01-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714319 on ClinicalTrials.gov