CMD-MINOCA: Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MINOCA with CMD MINOCA patients with CMD proven by invasive or non-invasive method |
Diagnostic Test: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
|
| MINOCA without CMD MINOCA patients without CMD |
Diagnostic Test: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
|
Outcome Measures
Primary Outcome Measures
- MACCE [2-Year after enrollment]
a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure
Secondary Outcome Measures
- cardiac death [2-Year after enrollment]
death from cardiac-cause
- all-cause death [2-Year after enrollment]
death from any-cause
- Rate of myocardial infarction [2-Year after enrollment]
any type of myocardial infarction
- 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
- 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
- Changes of Coronary flow reserve [6-Month after enrollment]
Coronary flow reserve by PET
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject with age ≥19 years and acute myocardial infarction
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Rise and/or fall of cardiac troponin with one level >99 percentile plus ischemic signs/symptoms
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Subject with non-obstructive coronary arteries
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<50% diameter stenosis or
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fractional flow reserve (FFR) >0.80 ③ Subject without previous history of coronary artery disease
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Subject who performed invasive coronary angiography within 24 hours after presentation ⑤ Subject who eligible for invasive and non-invasive coronary physiologic assessment
Exclusion Criteria:
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Subject with obstructive coronary arteries
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Subject with alternate diagnosis including sepsis, pulmonary embolism, myocarditis, Takotsubo syndrome, spontaneous coronary dissection, and other cardiomyopathies.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonnam National University Hospital | Gwangju | Korea, Republic of | 61469 |
Sponsors and Collaborators
- Chonnam National University Hospital
- Korean Cardiac Research Foundation
- Abbott
Investigators
- Principal Investigator: Young Joon Hong, MD, PhD, Chonnam National University Medical School; Chonnam National University Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- CNUH-2021-413