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Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

NCT ID: NCT00479895

Last Updated: 2008-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Coronary Occlusion Acute Coronary Syndrome

Keywords

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Percutaneous Coronary Intervention Myocardial Ischemia Balloon Occlusion Catheter Lab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion

Group Type OTHER

Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

Intervention Type DRUG

Pre-oxygenated HBOC-201

2

Dry occlusion followed by occlusion with pre-oxygenated HBOC-201

Group Type OTHER

Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

Intervention Type DRUG

Pre-oxygenated HBOC-201

Interventions

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Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

Pre-oxygenated HBOC-201

Intervention Type DRUG

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biopure Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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A. Gerson Greenburg, MD, PhD

Role: STUDY_DIRECTOR

Biopure Corporation

Locations

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Thoraxcentre - Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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COR-0002

Identifier Type: -

Identifier Source: org_study_id