Clinical Trial: Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II, Open-Label Study in the Catheterization Laboratory Setting to Challenge the Concept That HBOC-201 Administration Might Improve Myocardial 'Oxygenation' and Myocardial Function at the Moment

Brief Summary: The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier, HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for surgical patients, has the ability to restore tissue oxygenation in persistently ischemic tissue. The development of this new class of compounds, referred to as oxygen therapeutics, provides an opportunity to test the safety and efficacy of a new approach to management of myocardial ischemia.

Detailed Summary: Because of their ability to perfuse and deliver oxygen, hemoglobin-based oxygen carriers (HBOC) may be considered in the treatment of several ischemic conditions, such as acute coronary syndromes (ACS). Elective percutaneous intervention (PCI) induces transient myocardial ischemia due to reduction of coronary flow during balloon inflation in the coronary artery, thus simulating in a control setting, the occurrence of an ACS.
Sponsor: Biopure Corporation

Current Primary Outcome: To study the change in left ventricular relaxation indices and pressure-half time and the change in the sum of ST segment deviations compared to baseline. [ Time Frame: Duration of the study ]

Original Primary Outcome: To study the change in left ventricular relaxation indices and pressure-half time and the change in the sum of ST segment deviations compared to baseline.

Current Secondary Outcome: LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints [ Time Frame: Duration of the study ]

Original Secondary Outcome: LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints

Information By: Biopure Corporation

Dates:
Date Received: May 25, 2007
Date Started: April 2007
Date Completion:
Last Updated: May 29, 2008
Last Verified: May 2008