Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II) (AMIHOT II)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Heart Attack
Eligibility Criteria
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
Sites / Locations
- Bryn Mawr Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
1
2
Control - Patients with acute anterior myocardial infarction revascularized by means of PCI with stenting within 6 hours of onset of symptoms, no experimental intervention
AO Therapy group - anterior acute myocardial infarction patients revascularized by means of PCI with stenting within 6 hours of symptom onset, receiving adjunctive infusion of hyperoxemic blood into target coronary artery for 90 minutes post-PCI.