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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00691834
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years of age and no more than 80 years of age.
* Acute ST-segment elevation MI
* Symptoms suggestive of acute MI
* ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
* Time from symptom onset to enrollment \< 120 hours
* Left ventricular dysfunction by contrast ventriculography or echocardiography
* EF above 25 % and lower than 40%
* Focal wall motion akinesis or dyskinesis
* Clearly identifiable infarct artery
* Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement
Exclusion Criteria:
* Planned treatment with bypass surgery or prior CABG
* Multi-vessel PCI
* Prior myocardial infarction by history or presence of pathologic Q-waves
* Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
* Successful reperfusion \< 3 hrs from symptom onset
* Prior MI or significant chronic heart failure
* Pacemaker/defibrillator
* Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
* Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\<25 and/or serum Cr \>2.5 mg/dl)
* Baseline hematocrit \< 30
* Pregnancy, or lactation/parturition within the past 30 days
* Active or planned treatment with chemotherapy
* Anticipated difficulty with 90-day follow-up
* Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
* Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
* Previous enrollment in this trial
* Participation in an investigational drug or device study within the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00691834
Study Brief:
Protocol Section:
NCT00691834