Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

This study has been completed.
Sponsor:
Information provided by:
Biopure Corporation
ClinicalTrials.gov Identifier:
NCT00479895
First received: May 25, 2007
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Coronary Occlusion
Acute Coronary Syndrome
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biopure Corporation:

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. [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

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 [ Time Frame: Duration of the study ]

Enrollment: 5
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201
2
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00479895

Locations
Netherlands
Thoraxcentre - Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
Biopure Corporation
Investigators
Study Director: A. Gerson Greenburg, MD, PhD Biopure Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00479895     History of Changes
Other Study ID Numbers: COR-0002
Study First Received: May 25, 2007
Last Updated: May 29, 2008
Health Authority: Netherlands: Medical Ethics Review Committee of the Erasmus Medical Center, Rotterdam

Keywords provided by Biopure Corporation:
Percutaneous Coronary Intervention
Myocardial Ischemia
Balloon Occlusion
Catheter Lab

Additional relevant MeSH terms:
Coronary Occlusion
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
HBOC 201
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014