Coronary OcclusionPhase 2NCT00479895
Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
A Phase 2 study testing Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) in people with Coronary Occlusion and Acute Coronary Syndrome, run by Biopure Corporation at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Occlusion, Acute Coronary Syndrome
- What is being tested?
- Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Coronary Occlusion, Acute Coronary Syndrome
- Being tested
- Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
- Keywords
- Percutaneous Coronary Intervention, Myocardial Ischemia, Balloon Occlusion, Catheter Lab
- Medical subject headings
- Coronary Occlusion, Acute Coronary Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)Drug
Pre-oxygenated HBOC-201
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion Receives: Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) |
| 2 | Other | Dry occlusion followed by occlusion with pre-oxygenated HBOC-201 Receives: Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of the study
Secondary outcomes (1)
LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biopure Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Gerson Greenburg, MD, PhD, Study director, Biopure Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479895
- Sponsor's protocol ID
- COR-0002
- Status last verified
- May 2008
- First submitted
- 25 May 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00479895
- Acronym / sponsor ID
- COR-0002
- Conditions
- Coronary Occlusion, Acute Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention, Myocardial Ischemia, Balloon Occlusion, Catheter Lab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Biopure CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion |
| 2 | Other | Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)Dry occlusion followed by occlusion with pre-oxygenated HBOC-201 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)Pre-oxygenated HBOC-201 | Drug | 1, 2 |
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
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Gerson Greenburg, MD, PhD study director
Biopure Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) in people with Coronary Occlusion and Acute Coronary Syndrome, run by Biopure Corporation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.