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

NCT05272618 | Recruiting DMC

• 1 other identifier: CNUH-2021-413
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Microvascular Dysfunction; Vasospasm, Coronary

Keywords

MINOCA; Coronary physiology; Cardiac PET; CFR; IMR; OCT

Outcome Measures

Primary Outcomes (1)

• MACCE

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

  2-Year after enrollment

Secondary Outcomes (9)

• cardiac death

  2-Year after enrollment

• all-cause death

  2-Year after enrollment

• Rate of myocardial infarction

  2-Year after enrollment

• Rate of repeat revascularization

  2-Year after enrollment

• Rate of stroke

  2-Year after enrollment

Study Arms (2)

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)

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)

Interventions

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)

MINOCA with CMD; MINOCA without CMD

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Korean Cardiac Research Foundation: collaborator
• Abbott: collaborator

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Coronary Vasospasm; MINOCA

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Young Joon Hong, MD, PhD

  Chonnam National University Medical School; Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: February 14, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December 31, 2026 \~
• Access Criteria: Not specified. To be discussed.

Locations

KR (1)