Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorChonnam National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
Diagnostic testIntravascular imaging (OCT), Invasive physiologic assessment (FFR, CFR, IMR), or Non-invasive physiologic assessment (N-13 ammonia PET)
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: MINOCA with CMD1 intervention
Group B: MINOCA without CMD1 intervention
Trial outcomes
Primary outcomes
1
MACCE
a composite of cardiac death, any MI, any revascularization, stroke, readmission due to heart failure
Time frame
2-Year after enrollmentSecondary outcomes
1
cardiac death
death from cardiac-cause
Time frame
2-Year after enrollment2
all-cause death
death from any-cause
Time frame
2-Year after enrollment3
Rate of myocardial infarction
any type of myocardial infarction
Time frame
2-Year after enrollment4
Rate of repeat revascularization
ischemia-driven or all
Time frame
2-Year after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chonnam National University Hospital
Lead sponsor
Korean Cardiac Research Foundation
Collaborator
Abbott
Collaborator
Source ClinicalTrials.gov