Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries

Recruiting

• Conditions: Coronary Microvascular Dysfunction; Myocardial Infarction; Vasospasm, Coronary
• Interventions: Diagnostic Test: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)

• Registration Number: NCT05272618
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

To compare clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) according to the coronary microvascular dysfunction (CMD), evaluated by optical coherence tomography (OCT), invasive and non-invasive coronary physiologic assessment.

Detailed Description

Background Approximately 5\~10% of patients with acute myocardial infarction (AMI) have been reported as myocardial infarction with non-obstructive coronary arteries (MINOCA) in the contemporary clinical setting. Although those with MINOCA have a better prognosis than with obstructive coronary artery disease, several observational studies continuously reported that patients with MINOCA showed comparable outcomes. One plausible explanation of this discrepancy is the heterogeneous and variable definition of MINOCA. Possible causes of MINOCA include plaque erosion and/or rupture, vasospasm, and CMD. Therefore, it is natural that heterogeneous pathophysiology of MINOCA causes diagnostic challenges and proper management.

Recently, there have been efforts for establishing the diagnosis of MINOCA and standardizing the systematic management according to the cause of MINOCA. According to the AHA scientific statement, patients who suspected MINOCA have been recommended to perform multimodality approach, including intravascular imaging (i.e., OCT). Although non-invasive methods, such as N-13 ammonia positron emission tomography (PET), can be used for evaluating the CMD, invasive coronary physiologic assessment using pressure-temperature wire has been recommended. CMD has been known as a major cause of MINOCA, and it may be required specific treatment.

Nevertheless, there has no data on the outcomes of MINOCA with or without CMD. Therefore, the aim of CMD-MINOCA sought to assess the MINOCA patients regarding the latest clinical pathway for diagnosis of CMD and evaluate their clinical outcomes at 2 years.

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-31
• Last Update Posted: 2024-01-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subject with age ≥19 years and acute myocardial infarction

  • Rise and/or fall of cardiac troponin with one level >99 percentile plus ischemic signs/symptoms

    • Subject with non-obstructive coronary arteries

  • <50% diameter stenosis or

  • fractional flow reserve (FFR) >0.80 ③ Subject without previous history of coronary artery disease

    • Subject who performed invasive coronary angiography within 24 hours after presentation ⑤ Subject who eligible for invasive and non-invasive coronary physiologic assessment

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Exclusion Criteria

• Subject with obstructive coronary arteries

  • Subject with alternate diagnosis including sepsis, pulmonary embolism, myocarditis, Takotsubo syndrome, spontaneous coronary dissection, and other cardiomyopathies.

    • Subject with cardiogenic shock or cardiac arrest ④ Subject who has non-cardiac co-morbid conditions with life expectancy <1 year ⑤ Subject or lactating women ⑥ Subject unable to provide consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MINOCA with CMD	Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)	MINOCA patients with CMD proven by invasive or non-invasive method
MINOCA without CMD	Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)	MINOCA patients without CMD

Primary Outcome Measures

Name	Time	Method
MACCE	2-Year after enrollment	a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure

Secondary Outcome Measures

Name	Time	Method
cardiac death	2-Year after enrollment	death from cardiac-cause
re-admission due to heart failure	2-Year after enrollment	re-admission due to heart failure
all-cause death, any MI, or any revascularization	2-Year after enrollment	a composite of all-cause death, any myocardial infarction, or any revascularization
Changes of left ventricular ejection fraction	2-Year after enrollment	left ventricular ejection fraction by echocardiography
Rate of myocardial infarction	2-Year after enrollment	any type of myocardial infarction
Changes of Coronary flow reserve	6-Month after enrollment	Coronary flow reserve by PET
Rate of repeat revascularization	2-Year after enrollment	ischemia-driven or all
Rate of stroke	2-Year after enrollment	ischemic or hemorrhagic stroke by brain imaging
all-cause death	2-Year after enrollment	death from any-cause

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of