Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II)

NCT00175058 | Completed Phase 3 DMC

• 1 other identifier: AMIHOT II
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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, results in a significant reduction in infarct size as measured by SPECT @ 14 days post event.

Conditions

Myocardial Infarction

Keywords

Heart Attack

Outcome Measures

Primary Outcomes (2)

• A single SPECT scan will be used to determine whether or not the treatment results in a significant reduction in infarct size in the treatment group. The scan is performed 14 days post-event.

  14 +/- 7 days

• Safety will be determined by comparing 30-day MACE (Major Adverse Cardiac Events) rates, where MACE is comprised by the combined incidence of death, stroke, repeat MI, and target vessel revascularization.

  30 days

Secondary Outcomes (1)

• ST elevation reduction will be compared between the two randomized groups at 3, 4, and 6 hours post-intervention

  3, 4, and 6 hrs post-intervention

Study Arms (2)

1

NO INTERVENTION

Control - Patients with acute anterior myocardial infarction revascularized by means of PCI with stenting within 6 hours of onset of symptoms, no experimental intervention

2

EXPERIMENTAL

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.

Device: AO Therapy (aqueous oxygen)

Interventions

AO Therapy (aqueous oxygen) DEVICE

90-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting

Also known as: AO Therapy, SSO2 Therapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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)
• 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
• Any proximal coronary diameter stenosis \> 40 % that would restrict native flow with the Tracker-38 infusion catheter in place

Sponsors & Collaborators

• TherOx: lead

Study Sites (1)

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Related Publications (1)

• Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.

  PMID: 20031745 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: May 1, 2008
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (1)