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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01319760
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Signed Informed Consent
* Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads (V1-V3)
* Primary PCI performed within 5 hours of the onset of symptoms
* Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
* Successful revascularization of the culprit native coronary artery with TIMI Flow Grade of 3 at the end of PCI
Exclusion Criteria:
* Cardiac arrest requiring CPR within 24 hours prior to enrollment
* Current cardiogenic shock
* Left Bundle Branch Block (new or old)
* Atrial fibrillation
* Known history of prior MI
* Prior coronary artery bypass graft surgery
* Known mural thrombus in the left ventricle or contraindication to left ventriculography
* Presence of a mechanical aortic valve
* Documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency.
* Known history of severe kidney dysfunction.
* Known contraindication to MRI (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds).
* History of recent (within 1 month) stroke or TIA
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
* Administration of fibrinolytic therapy within 24 hours
* Known hypersensitivity or contraindication to any of the following: Heparin, pork or pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel
* Contrast media Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.
* Severe peripheral arterial obstructive disease that would preclude the IMPELLA® System placement
* Requirement to treat two or more culprit vessels during primary PCI, or plan for staged coronary revascularization (PCI or CABG) within the next 30 days.
* Inability to place Impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01319760
Study Brief:
Protocol Section:
NCT01319760