Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II)

Completed · Phase 3

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00175058

Run by

TherOx

People needed

317

Starts

2005-08-01

Expected to finish

2008-05-01

Last updated by the study team

2012-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States

Full record on ClinicalTrials.gov

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