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| Name | Class |
|---|---|
| Korean Cardiac Research Foundation | UNKNOWN |
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINOCA with CMD | MINOCA patients with CMD proven by invasive or non-invasive method |
| |
| MINOCA without CMD | MINOCA patients without CMD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET) | Diagnostic Test | Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET) |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure | 2-Year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac death | death from cardiac-cause | 2-Year after enrollment |
| all-cause death | death from any-cause | 2-Year after enrollment |
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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
<50% diameter stenosis or
fractional flow reserve (FFR) >0.80 â‘¢ Subject without previous history of coronary artery disease
Exclusion Criteria:
Subject with obstructive coronary arteries
Subject with alternate diagnosis including sepsis, pulmonary embolism, myocarditis, Takotsubo syndrome, spontaneous coronary dissection, and other cardiomyopathies.
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About 150 patients with suspected myocardial infarction underwent invasive coronary angiography, but without obstructive coronary arteries will be enrolled. These patients will be evaluated by OCT, coronary functional assessment including coronary spasm test, invasive (FFR, CFR, IMR) and non-invasive coronary physiologic assessment (N-13 ammonia positron emission tomography).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Joon Hong, MD, PhD | Contact | 82-10-2055-7919 | hyj200@hanmail.net | |
| Seung Hun Lee, MD, PhD | Contact | 82-10-6413-7449 | lsh8602@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Joon Hong, MD, PhD | Chonnam National University Medical School; Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Recruiting | Gwangju | Gwangju | 61469 | South Korea |
After the publication of the main paper, we have a plan to share IPD regarding the request.
December 31, 2026 ~
Not specified. To be discussed.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2022 |
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| Rate of myocardial infarction | any type of myocardial infarction | 2-Year after enrollment |
| Rate of repeat revascularization | ischemia-driven or all | 2-Year after enrollment |
| Rate of stroke | ischemic or hemorrhagic stroke by brain imaging | 2-Year after enrollment |
| re-admission due to heart failure | re-admission due to heart failure | 2-Year after enrollment |
| all-cause death, any MI, or any revascularization | a composite of all-cause death, any myocardial infarction, or any revascularization | 2-Year after enrollment |
| Changes of left ventricular ejection fraction | left ventricular ejection fraction by echocardiography | 2-Year after enrollment |
| Changes of Coronary flow reserve | Coronary flow reserve by PET | 6-Month after enrollment |
| Feb 28, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003329 | Coronary Vasospasm |
| D000088442 | MINOCA |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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