Status:
COMPLETED
Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II)
Lead Sponsor:
TherOx
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, re...
Detailed Description
The AMIHOT II clinical trial is designed as a focused study of a promising patient subset from the completed AMIHOT study. A brief synopsis of the AMIHOT experience is provided below, followed by a de...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Candidates for this study must meet ALL of the following criteria:
- Pre-PCI:
- Patient must be \>= 18 years of age
- AMI must be anterior
- Patient is experiencing clinical symptoms consistent with anterior AMI of \< 6 hour duration from time of symptom onset until admission to the emergency room
- Complete medical history, history of AMI, previous coronary interventions, list of medications given within last 24 hours
- 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)
- Patient provides written, Informed Consent
- Patient and his/her physician agree to all required follow-up procedures and visits
- 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:
- Based on coronary anatomy, PCI is indicated for culprit lesion with anticipated use of an Intra-Coronary Stent
- TIMI 0, I, or II flow is present on the initial angiographic injection of the infarct-related artery
- 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
- 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:
- Patients with ventricular pseudoaneurysm, VSD, or papillary muscle rupture.
- Absolute contraindications to anticoagulant therapy, including hemorrhagic diathesis or thrombocytopenia
- Systemic Arterial pO2 is \< 80 mmHg with supplemental oxygen
- Placement of an intra-aortic balloon pump (IABP)
- Patient has had coronary bypass surgery during the 30 day period preceding PCI
- Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy
- Patients requiring cardiopulmonary resuscitation for \> 10 minutes
- Cardiogenic shock (SBP \< 80 mm Hg for more than 30 minutes unresponsive to fluids or requiring intravenous pressors or placement of an IABP)
- Expected survival of less than 6 months due to non-cardiac condition
- Current participation in other investigational device or drug trials that have not finished the primary efficacy endpoint follow-up parameters
- Patient has had a hemorrhagic stroke during the 6 month period preceding PCI
- Physician discretion regarding unacceptability for enrollment
- ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to randomization:
- Any proximal coronary diameter stenosis \> 40 % that would restrict native flow with the Tracker-38 infusion catheter in place
- Infarct-related vessels that are either saphenous vein grafts and/or small second order coronary vessels that do not supply significant areas of myocardium
- Presence of a non-stented coronary dissection upon completion of the PCI procedure
- Unprotected left main diameter stenosis \> 60%
- Severe target vessel calcification or tortuosity
- Multi - vessel disease that in the judgment of the investigator is best treated with emergent or urgent CABG or additional PCI within 30 days
- In the investigator's opinion, the target vessel is unsuitable for either placing the infusion catheter or treatment with PCI
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00175058
Start Date
August 1 2005
End Date
May 1 2008
Last Update
June 18 2012
Active Locations (1)
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1
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010