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Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II)

Sponsored by TherOx

About this trial

Last updated 13 years ago

Study ID

AMIHOT II

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 17 years ago

What is this trial about?

To determine whether or not HyperOxemic therapy rendered to patients (that meet the study inclusion criteria) with anterior acute myocardial infarction < 6 hours from symptom onset to reperfusion, results in a significant reduction in infarct size as measured by SPECT @ 14 days post event.

What are the participation requirements?

Yes

Inclusion Criteria

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

No

Exclusion Criteria

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