Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries (CMD-MINOCA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Microvascular Dysfunction; Vasospasm, Coronary
• Intervention / Treatment: Diagnostic test: Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Young Joon Hong, MD, PhD; Phone Number: 82-10-2055-7919; Email: hyj200@hanmail.net
• Study Contact Backup: Name: Seung Hun Lee, MD, PhD; Phone Number: 82-10-6413-7449; Email: lsh8602@naver.com

Study Locations

• South Korea
  • Gwangju
    • Gwangju, Gwangju, South Korea, 61469
      • Recruiting
      • Chonnam National University Hospital
      • Contact: Young Joon Hong, MD, PhD; Phone Number: 82-10-2055-7919; Email: hyj200@hanmail.net
      • Contact: Seung Hun Lee, MD, PhD; Phone Number: 82-10-6413-7449; Email: lsh8602@naver.com
      • Sub-Investigator: Seung Hun Lee, MD, PhD
      • Principal Investigator: Young Joon Hong, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure	2-Year after enrollment

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Abbott; Korean Cardiac Research Foundation
• Investigators: Principal Investigator: Young Joon Hong, MD, PhD, Chonnam National University Medical School; Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: OCT; Coronary physiology; MINOCA; CFR; IMR; Cardiac PET
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Coronary Disease; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; MINOCA; Myocardial Infarction; Coronary Vasospasm; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: CNUH-2021-413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the publication of the main paper, we have a plan to share IPD regarding the request.
• IPD Sharing Time Frame: December 31, 2026 ~
• IPD Sharing Access Criteria: Not specified. To be discussed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No