At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intracoronary Provocative Test With Acetylcholine in Patients With Stable Myocardial Ischemia or Myocardial Infarction and Non-Obstructive Coronary Arteries: the "Provoke" Study
In Brief
An observational study evaluating Data collection and Clinical follow-up for Myocardial Infarction With Non-Obstructive Coronary Artery and Ischemia With Non-Obstructive Coronary Artery. Currently recruiting, targeting 600 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.