Intracoronary Provocative Test With Acetylcholine in Patients With Stable Myocardial Ischemia or Myocardial Infarction and Non-Obstructive Coronary Arteries: the Provoke Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Rocco A Montone, MD, PhD
roccoantonio.montone@policlinicogemelli.it
+39-0630154187
Time Frame
Start Date: 2023-01-12
Estimated Completion Date: 2028-01-12
Participants
Target number of participants: 600
Treatments
MINOCA
Patients undergoing clinically indicated CAG for suspected myocardial ischemia with angiographic evidence of non-obstructive CAD (angiographically normal coronary arteries or diffuse atherosclerosis with stenosis \<50% and/or fractional flow reserve \[FFR\] \>0.80 if coronary stenosis ranging from 40 to 49%) that underwent an intracoronary provocative test with ACh according to clinical practice and medical choice will be enrolled.~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: myocardial ischemia (1 or + episodes of chest pain at rest typical enough to suggest a cardiac ischemic origin in the previous 24 hours); new ischemic ECG changes; pathological Q waves; new loss of viable myocardium or regional wall motion abnormality consistent with an ischemic aetiology.
INOCA
All consecutive patients undergoing clinically indicated CAG for suspected myocardial ischemia with angiographic evidence of non-obstructive CAD (angiographically normal coronary arteries or diffuse atherosclerosis with stenosis \<50% and/or fractional flow reserve \[FFR\] \>0.80 if coronary stenosis ranging from 40 to 49%) that underwent an intracoronary provocative test with ACh as suggested in current guidelines and consensus and according to clinical practice and medical choice will be consecutively included in this 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.
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov