Eligibility Module

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: 2025-12-24 @ 7:18 PM
Ignite Modification Date: 2025-12-24 @ 7:18 PM
NCT ID: NCT00399503
Eligibility Criteria: Inclusion Criteria: * Confirmed MI \<31 days, based upon elevated cardiac-specific CK (total CK-MB mass \>7ng/mL or CK-MB/total CK ≥ 2.5%) or troponin-T (\> 0.1 ng/ml)144) plus * clinical symptoms or ECG evidence of myocardial injury (ST deviation ≥ 1 mm in 2, contiguous leads or new/previously undocumented Q waves)144, \& * left ventricular ejection fraction ≤ 0.40 within 48 hrs or ≤ 0.50 beyond 48 hrs of MI using (echocardiography, radionuclide or contrast angiography) \& * Sinus rhythm at the time of enrollment. Exclusion Criteria: * Geographic isolation or inability to return for follow-up, * Comorbid illness likely to cause death within 24 months, * Inability to complete a submaximal exercise test (e.g., urgent CABG), * Class I indication for a defibrillator (e.g., VF or sustained VT \> 48 hours of index MI), or * Lack of written informed consent
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT00399503
Study Brief:
Protocol Section: NCT00399503