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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02976467
Eligibility Criteria:
Inclusion Criteria:
* Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
* Diagnosis of STEMI requires the presence of the following three criteria:
* Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes related to the myocardial infarction
* New ST elevation indicating myocardial infarction
* Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and/or elevation creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
* At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size \>10% LV mass (as measured by LGE-MRI, central-blinded evaluation)
Exclusion Criteria:
* Contraindication to perform contrast-enhanced cardiac MRI
* LVEF \< 20%
* History of heart failure or LVEF \< 50% before occurrence of the first STEMI
* Infarct size \> 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
* NYHA (New York Heart Association) class IV at randomization
* Any planned cardiac intervention after baseline MRI or any other planned operations
* Non-ischemic causes for cardiomyopathy
* Diagnosis of atrial fibrillation
* Systolic blood pressure \< 100 mm Hg or \> 180 mm Hg; diastolic blood pressure \< 50 mm Hg or \>110 mm Hg, heart rate \< 50 or \>100 beat/minute; mean of triplicate values at randomization
* Clinically relevant hepatic dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
79 Years
Study:
NCT02976467
Study Brief:
Protocol Section:
NCT02976467