Myocardial infarction with nonobstructive coronary arteries (MINOCA) heart infarction with normal coronary arteries
Conditions
Interventions
160 patients with MINOCA will be 1:1 randomized to routine CFT added to standard care or standard care. Routine CFT consist of three-vessel CMD assessment (by coronary physiology measurements of CFR/I
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MINOCA diagnosis at index coronary angiography 2. At least 18 years of age 3.Oral consent for EDIT-MINOCA 4. In case of NSTEMI: High-sensitivity cardiac troponin T cut off value >52 ng/L or High-sensitivity cardiac troponin I cut off value according to the values stated in Table S4 in the 2023 ESC guidelines for the management of acute coronary syndrome
Exclusion criteria
Exclusion criteria: 1. Patients with limited life expectancy (<1 year) 2. Pregnancy, or active desire to become pregnant in the upcoming month 3. Contra-indication to cardiac magnetic resonance imaging 4. Contra-indication to intravenous adenosine 5. Previous Coronary Artery Bypass Grafting (CABG) 6. Reasonable suspicion for late gadolinium enhancement (LGE) due to previous myocardial infarction 7. Known severe valvular heart disease 8. Severe renal dysfunction, defined as eGFR <30 mL/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of identified diagnoses by routine CFT plus standard care versus standard care (OCT, CMR and elective CFT) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess quality of life and angina outcomes at 12-month follow-up.Net adverse clinical events are defined as death, cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for chest pain/discomfort, emergency department visits for chest pain/discomfort, transient ischemic attack, bleeding complications (BARC 2 or higher) and congestive heart failure.Major adverse cardiovascular events are defined as cardiovascular death, myocardial infarction, stroke, coronary revascularization, bleeding complications (BARC 2 or higher) and congestive heart failure.The number of correctly identified culprit vessels by physiology/OCT compared to standard diagnostic work up with CMR confirmed myocardial infarction as the gold standard. We expect to identify more CMR confirmed MI in the combined physiology plus OCT arm versus the control arm. Definitions are as follows: CMR-confirmed MI: late gadolinium enhancement with a distribution pattern consistent with myocardial infarctionCoronary physiology is considered abnormal if: CFR <2.5 and/or IMR >25 (assessed per vessel) in the infarcted area on CMR.Positive intracoronary imaging culprit defined as plaque rupture/erosion, thrombus, intra-plaque cavity, eruptive calcified nodule, or coronary dissection in the CMR-indicated infarct areaDemonstrated spasm (either microvascular spasm and/or epicardial spasm) in the coronary artery supplying the infarcted area on CMR | — |
Countries
Netherlands
Contacts
Public ContactB Yosofi
Radboud Universitair Medisch Centrum
Outcome results
None listed