Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT05326828
Eligibility Criteria:
Inclusion Criteria ICM group
1. ≥18 years of age
2. Written informed consent
3. Acute myocardial infarction (AMI) type 1 in accordance with the 4th universal definition of myocardial infarction
4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
5. No clinically overt specific cause for the acute presentation
6. Subendocardial or transmural late gadolinum enhancement (LGE) consistent with an ischemic etiology on cardiac magnetic resonance imaging (CMR)
7. No clear underlying cause of MINOCA and therefore increased probability of atrial fibrillation
Exclusion Criteria ICM group:
1. Known atrial fibrillation or atrial flutter
2. History of atrial fibrillation or atrial flutter ablation
3. Known coronary artery disease
4. Previous MI
5. Previous percutaneous coronary intervention (PCI)
6. Previous coronary artery bypass grafting (CABG)
7. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, glomerular filtration rate (GFR) \<30 ml/min)
8. Contraindications to ICM implantation
9. Clear underlying cause of MINOCA before ICM implantation
Inclusion Criteria non-ICM group:
1. ≥18 years of age
2. Written informed consent
3. AMI type 1 in accordance with the 4th universal definition of myocardial infarction
4. Non-obstructive coronary arteries on angiography defined as the absence of coronary artery stenoses ≥50% in any potential infarct-related artery
5. No clinically overt specific cause for the acute presentation
6. Subendocardial or transmural LGE consistent with an ischemic etiology on CMR
Exclusion Criteria non-ICM group:
1. Known coronary artery disease
2. Previous MI
3. Previous PCI
4. Previous CABG
5. Contraindications to CMR (i.e. non-MR-compatible implantable cardiac device, GFR \<30 ml/min)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05326828
Study Brief:
Protocol Section:
NCT05326828