Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

May 29, 2008 updated by: Biopure Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Thoraxcentre - Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201
Other: 2
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopure Corporation

Investigators

  • Study Director: A. Gerson Greenburg, MD, PhD, Biopure Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 25, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 29, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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