Assessing coronary microvascular dysfunction in heart attacks without blocked arteries
Clinical Relevance of Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
This study is trying to see how problems with small blood vessels in the heart affect people who have heart attacks but don’t have blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chonnam National University Hospital Academic / other |
| Locations | 1 site (Gwangju, Gwangju) |
| Trial ID | NCT05272618 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare clinical outcomes in patients experiencing myocardial infarction with non-obstructive coronary arteries (MINOCA) by evaluating coronary microvascular dysfunction (CMD) using various assessment techniques. The study will utilize both invasive methods, such as optical coherence tomography (OCT) and pressure-temperature wire assessments, and non-invasive methods like N-13 ammonia positron emission tomography (PET). By understanding the role of CMD in MINOCA, the study seeks to standardize diagnosis and management approaches for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who have experienced an acute myocardial infarction with non-obstructive coronary arteries.
Not a fit: Patients with obstructive coronary arteries or alternate diagnoses such as myocarditis or Takotsubo syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with MINOCA, enhancing their clinical outcomes.
How similar studies have performed: While there have been efforts to standardize the management of MINOCA, this study's specific focus on CMD assessments is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gwangju, Gwangju
- Chonnam National University Hospital — Gwangju, Gwangju, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Joon Hong, MD, PhD — Chonnam National University Medical School; Chonnam National University Hospital
- Study coordinator: Young Joon Hong, MD, PhD
- Email: hyj200@hanmail.net
- Phone: 82-10-2055-7919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.