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

Myocardial Infarction Clinical Trial

— CMD-MINOCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272618
• Other study ID #: CNUH-2021-413
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Chonnam National University Hospital
• Contact: Young Joon Hong, MD, PhD
• Phone: 82-10-2055-7919
• Email: hyj200[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 ? Subject without previous history of coronary artery disease
• Subject who performed invasive coronary angiography within 24 hours after presentation ? Subject who eligible for invasive and non-invasive coronary physiologic assessment

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 ? Subject who has non-cardiac co-morbid conditions with life expectancy <1 year ? Subject or lactating women ? Subject unable to provide consent

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction
• Coronary Vasospasm
• Infarction
• Myocardial Infarction

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (3)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Abbott, Korean Cardiac Research Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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