Acute Myocardial Infarction With HyperOxemic Therapy II (AMIHOT II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TherOx
ClinicalTrials.gov Identifier:
NCT00175058
First received: September 9, 2005
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Device: AO Therapy (aqueous oxygen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Myocardial Infarction With HyperOxemic Therapy II

Resource links provided by NLM:


Further study details as provided by TherOx:

Primary Outcome Measures:
  • 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. [ Time Frame: 14 +/- 7 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ST elevation reduction will be compared between the two randomized groups at 3, 4, and 6 hours post-intervention [ Time Frame: 3, 4, and 6 hrs post-intervention ] [ Designated as safety issue: No ]

Enrollment: 317
Study Start Date: August 2005
Study Completion Date: May 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control - Patients with acute anterior myocardial infarction revascularized by means of PCI with stenting within 6 hours of onset of symptoms, no experimental intervention
Experimental: 2
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)
90-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting
Other Names:
  • AO Therapy
  • SSO2 Therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

Candidates for this study must meet ALL of the following criteria:

Pre-PCI:

  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

    EXCLUSION CRITERIA

    Candidates will be excluded from this study if ANY of the following conditions apply:

    Pre-PCI:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175058

Locations
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
TherOx
  More Information

No publications provided by TherOx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TherOx
ClinicalTrials.gov Identifier: NCT00175058     History of Changes
Other Study ID Numbers: AMIHOT II
Study First Received: September 9, 2005
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by TherOx:
Heart Attack

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014