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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00175058
Eligibility Criteria:
INCLUSION CRITERIA
Candidates for this study must meet ALL of the following criteria:
Pre-PCI:
1. Patient must be \>= 18 years of age
2. AMI must be anterior
3. Patient is experiencing clinical symptoms consistent with anterior AMI of \< 6 hour duration from time of symptom onset until admission to the emergency room
4. Complete medical history, history of AMI, previous coronary interventions, list of medications given within last 24 hours
5. 12-lead qualifying ECG criteria: Anterior infarction (ST-segment elevation \> 1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block (LBBB) with documentation of LAD system culprit lesion)
6. Patient provides written, Informed Consent
7. Patient and his/her physician agree to all required follow-up procedures and visits
8. Women of childbearing potential who have a negative pregnancy test (applies to female patients only)
ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to randomization:
9. Based on coronary anatomy, PCI is indicated for culprit lesion with anticipated use of an Intra-Coronary Stent
10. TIMI 0, I, or II flow is present on the initial angiographic injection of the infarct-related artery
11. Successful angioplasty as documented by \< 50% diameter residual angiographic stenosis within and associated with the culprit lesion and ³ TIMI II flow and no major complications such as perforation or shock
12. Documented time of reperfusion is \< 6 hours from the documented time of symptom onset
EXCLUSION CRITERIA
Candidates will be excluded from this study if ANY of the following conditions apply:
Pre-PCI:
13. Patients with ventricular pseudoaneurysm, VSD, or papillary muscle rupture.
14. Absolute contraindications to anticoagulant therapy, including hemorrhagic diathesis or thrombocytopenia
15. Systemic Arterial pO2 is \< 80 mmHg with supplemental oxygen
16. Placement of an intra-aortic balloon pump (IABP)
17. Patient has had coronary bypass surgery during the 30 day period preceding PCI
18. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy
19. Patients requiring cardiopulmonary resuscitation for \> 10 minutes
20. Cardiogenic shock (SBP \< 80 mm Hg for more than 30 minutes unresponsive to fluids or requiring intravenous pressors or placement of an IABP)
21. Expected survival of less than 6 months due to non-cardiac condition
22. Current participation in other investigational device or drug trials that have not finished the primary efficacy endpoint follow-up parameters
23. Patient has had a hemorrhagic stroke during the 6 month period preceding PCI
24. Physician discretion regarding unacceptability for enrollment
ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to randomization:
25. Any proximal coronary diameter stenosis \> 40 % that would restrict native flow with the Tracker-38 infusion catheter in place
26. Infarct-related vessels that are either saphenous vein grafts and/or small second order coronary vessels that do not supply significant areas of myocardium
27. Presence of a non-stented coronary dissection upon completion of the PCI procedure
28. Unprotected left main diameter stenosis \> 60%
29. Severe target vessel calcification or tortuosity
30. Multi - vessel disease that in the judgment of the investigator is best treated with emergent or urgent CABG or additional PCI within 30 days
31. In the investigator's opinion, the target vessel is unsuitable for either placing the infusion catheter or treatment with PCI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00175058
Study Brief:
Protocol Section:
NCT00175058