Intracoronary Provocative Test With Acetylcholine in Patients With INOCA and MINOCA

NCT05714319 | Recruiting

• 1 other identifier: 5404
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MINOCA; INOCA

Outcome Measures

Primary Outcomes (1)

• Assess clinical predictors for a positive ACh test response

  To assess for the presence of clinical predictors for a positive ACh test response in INOCA and MINOCA patients that could be used to develop and validate predictive models and/or clinical risk scores for a positive ACh test.

  Up to 30 days

Secondary Outcomes (1)

• Assess clinical predictors for MACCE

  Up to 2 years

Study Arms (2)

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.

Other: Data collection; Other: Clinical follow-up

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.

Other: Data collection; Other: Clinical follow-up

Interventions

Data collection OTHER

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.

INOCA; MINOCA

Clinical follow-up OTHER

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.

INOCA; MINOCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the Department of Cardiovascular Sciences of Fondazione Policlinico Universitario A. Gemelli IRCCS since January 1, 2020 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. Both patients admitted with suspected INOCA and MINOCA, diagnosed according to the most recent guidelines, will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• Patient that did not undergo an intracoronary provocative test with ACh at the time of CAG.
• Among patients presenting with suspected MINOCA, those with obvious causes of MI other than suspected coronary vasomotor abnormalities will be excluded (e.g.: Takotsubo syndrome, suspected diagnosis of myocarditis, pulmonary embolism, evidence of coronary thrombosis on an unstable plaque confirmed by optical coherence tomography, cardiotoxic drug administration, hypertensive crisis or severe valvulopathies).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

MINOCA

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rocco A Montone, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco A Montone, MD, PhD

CONTACT

+39-0630154187; roccoantonio.montone@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IRCCS Researcher

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: January 12, 2023
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): January 12, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)