Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
Primary Purpose
Coronary Occlusion, Acute Coronary Syndrome
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Occlusion focused on measuring Percutaneous Coronary Intervention, Myocardial Ischemia, Balloon Occlusion, Catheter Lab
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent before initiation of any study-related procedure and agreement to comply with all protocol-specific procedures
- Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braundwald class 1-3, B) or documented silent ischemia
- Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances.
- Normal left ventricular wall motion on left ventricular angiogram or on echocardiogram with preserved systolic global LV function
- Non-occlusive stenosis, located in the proximal segments of the left anterior descending artery (LAD) (segments 6 and/or 7) and/or circumflex artery (CFX) (segments 11 and/or 12) or right coronary artery (RCA) (segments 1, 2 and/or 3) for which there is clinical indication to percutaneous treatment with coronary stenting
- Successful PCI with stenting on the target vessel
- Older than 18 years and younger than 80 years of age
Exclusion Criteria:
- Active ischemia at the initiation of the study procedure
- Non-ST segment elevation myocardial infarction
- History or ECG evidence of prior MI in the territory supplied by the vessel undergoing PCI, IV conduction defects/baseline ST-segment abnormalities on the surface ECG
- Moderate to severe aortic or mitral valve disease
- Evidence of LV hypertrophy on the echocardiogram IVS > 13 and/or PW > 13mm
- Angiographically visible collateral vessels to the target vessel
- Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (> 140/100mmHg)
- Uncompensated congestive heart failure or signs of pulmonary edema
- Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support
- Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
- Confirmed pregnancy
- Systemic mastocytosis
- Hypoxemia (need for mechanical ventilation
- Known history of COPD with FEV 1s < 1.0 liter
- Renal impairment: creatinine > 1.6 mg/dl
- Participation in another trial with an investigational drug or device including follow-up period, within the last 30 days before enrollment
Additional exclusion criteria at the end of PCI (before randomization)
- Coronary TIMI flow in the treated artery is less than 3
- Serious arrhythmias during/following the PCI was noted
- Coronary spasm following PCI
- Any deterioration in the subject's "risk" status between informed consent and randomization
Sites / Locations
- Thoraxcentre - Erasmus MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479895
Brief Title
Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
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 of (Brief) Coronary Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biopure Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion, Acute Coronary Syndrome
Keywords
Percutaneous Coronary Intervention, Myocardial Ischemia, Balloon Occlusion, Catheter Lab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
Arm Title
2
Arm Type
Other
Arm Description
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
Intervention Type
Drug
Intervention Name(s)
Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Intervention Description
Pre-oxygenated HBOC-201
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent before initiation of any study-related procedure and agreement to comply with all protocol-specific procedures
Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braundwald class 1-3, B) or documented silent ischemia
Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances.
Normal left ventricular wall motion on left ventricular angiogram or on echocardiogram with preserved systolic global LV function
Non-occlusive stenosis, located in the proximal segments of the left anterior descending artery (LAD) (segments 6 and/or 7) and/or circumflex artery (CFX) (segments 11 and/or 12) or right coronary artery (RCA) (segments 1, 2 and/or 3) for which there is clinical indication to percutaneous treatment with coronary stenting
Successful PCI with stenting on the target vessel
Older than 18 years and younger than 80 years of age
Exclusion Criteria:
Active ischemia at the initiation of the study procedure
Non-ST segment elevation myocardial infarction
History or ECG evidence of prior MI in the territory supplied by the vessel undergoing PCI, IV conduction defects/baseline ST-segment abnormalities on the surface ECG
Moderate to severe aortic or mitral valve disease
Evidence of LV hypertrophy on the echocardiogram IVS > 13 and/or PW > 13mm
Angiographically visible collateral vessels to the target vessel
Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (> 140/100mmHg)
Uncompensated congestive heart failure or signs of pulmonary edema
Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support
Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
Confirmed pregnancy
Systemic mastocytosis
Hypoxemia (need for mechanical ventilation
Known history of COPD with FEV 1s < 1.0 liter
Renal impairment: creatinine > 1.6 mg/dl
Participation in another trial with an investigational drug or device including follow-up period, within the last 30 days before enrollment
Additional exclusion criteria at the end of PCI (before randomization)
Coronary TIMI flow in the treated artery is less than 3
Serious arrhythmias during/following the PCI was noted
Coronary spasm following PCI
Any deterioration in the subject's "risk" status between informed consent and randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Gerson Greenburg, MD, PhD
Organizational Affiliation
Biopure Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Thoraxcentre - Erasmus MC
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
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Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
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