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NCT Number: NCT05272618

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location status: Recruiting

Location contact

Seung Hun Lee, MD, PhD

CONTACT

[email protected]

82-10-6413-7449

Seung Hun Lee, MD, PhD

SUB_INVESTIGATOR

Young Joon Hong, MD, PhD

CONTACT

[email protected]

82-10-2055-7919

Young Joon Hong, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. MACCE

    Time frame: 2-Year after enrollment

    a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure

Secondary outcomes

  1. cardiac death

    Time frame: 2-Year after enrollment

    death from cardiac-cause

  2. all-cause death

    Time frame: 2-Year after enrollment

    death from any-cause

  3. Rate of myocardial infarction

    Time frame: 2-Year after enrollment

    any type of myocardial infarction

  4. Rate of repeat revascularization

    Time frame: 2-Year after enrollment

    ischemia-driven or all

  5. Rate of stroke

    Time frame: 2-Year after enrollment

    ischemic or hemorrhagic stroke by brain imaging

  6. re-admission due to heart failure

    Time frame: 2-Year after enrollment

    re-admission due to heart failure

  7. all-cause death, any MI, or any revascularization

    Time frame: 2-Year after enrollment

    a composite of all-cause death, any myocardial infarction, or any revascularization

  8. Changes of left ventricular ejection fraction

    Time frame: 2-Year after enrollment

    left ventricular ejection fraction by echocardiography

  9. Changes of Coronary flow reserve

    Time frame: 6-Month after enrollment

    Coronary flow reserve by PET

Study contacts

Contact information is provided by the study sponsor or research team.

Seung Hun Lee, MD, PhD

CONTACT

[email protected]

82-10-6413-7449

Young Joon Hong, MD, PhD

CONTACT

[email protected]

82-10-2055-7919

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Abbott
  • Korean Cardiac Research Foundation

Registry information

Official study title

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

Acronym: CMD-MINOCA

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Mar 9, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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