Myocardial IschemiaPhase 2EPOetCECNCT00273767
Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB
A Phase 2 study testing epoetin beta in people with Myocardial Ischemia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary bypass surgery.
- Surgery not urgent.
- Left ventricular ejection fraction (LVEF) > 40.
- Informed consent form signed.
Who cannot join
- Valvular surgery.
- Surgery with beating heart, with or without cardiopulmonary bypass.
- Carotid bypass surgery.
- Myocardial infarction less than 30 days.
- Previous history of cardiac surgery.
- Kidney failure (creatinine > 200 µmol/l).
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- Uncontrolled hypertension.
- Unstable angina.
- Risk of deep venous thrombosis.
- Vascular cerebral attack less than 30 days.
- Malignant tumour.
- Phenylketonuria.
- Allergy to erythropoietin.
- Previous programmed blood donation.
- Pregnancy and feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass
The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.
Read the detailed description
A new property of erythropoietin (EPO), independent of its hematopoietic role, has recently been discovered. Indeed, it has been reported that this hormone, following binding to its cardiac or cerebral receptors, is able to induce a spectacular cellular protection against ischemic injury. These cardioprotective and neuroprotective effects have been observed experimentally in rodents as well as clinically in humans. In particular, our team has demonstrated that the administration of NeoRecormon® protects the heart against ischemia in the rat by significantly improving its recovery.
In view of these exciting experimental results and of the growing interest of the scientific community for cytoprotective effects of EPO, we are planning the first clinical study examining the cardiac and cerebral protective effects of EPO (NeoRecormon®) in the setting of cardiac surgery.
- Conditions
- Myocardial Ischemia
- Being tested
- epoetin beta, placebo
- Keywords
- troponin T, CK-MB, protein S-100, Cardiopulmonary Bypass, Erythropoietin
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin betaDrug
800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery
placeboDrug
60ml of NaCl IV slow
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | epoetin beta Receives: Drug: epoetin beta |
| 2 | Placebo comparator | placebo of NaCl Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass
Measured: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass
Secondary outcomes (2)
Area under curve and maximal plasmatic level of protein S-100 after cardiopulmonary bypass
Measured: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass
Blood level of erythropoietin
Measured: at injection and 6 hours after the end of cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Olivier CHAVANON, Pr, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273767
- Sponsor's protocol ID
- DCIC 05 04
- Acronym
- EPOetCEC
- Status last verified
- Dec 2009
- First submitted
- 6 Jan 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.
PubMed 15249178Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
PubMed 12435860Johnsson P, Backstrom M, Bergh C, Jonsson H, Luhrs C, Alling C. Increased S100B in blood after cardiac surgery is a powerful predictor of late mortality. Ann Thorac Surg. 2003 Jan;75(1):162-8. doi: 10.1016/s0003-4975(02)04318-7.
PubMed 12537211Joyeux-Faure M, Godin-Ribuot D, Ribuot C. Erythropoietin and myocardial protection: what's new? Fundam Clin Pharmacol. 2005 Aug;19(4):439-46. doi: 10.1111/j.1472-8206.2005.00347.x.
PubMed 16011730Kerbaul F, Giorgi R, Oddoze C, Collart F, Guidon C, Lejeune PJ, Villacorta J, Gouin F. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery. Br J Anaesth. 2004 Nov;93(5):639-44. doi: 10.1093/bja/aeh246. Epub 2004 Sep 3.
PubMed 15347604
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00273767
- Acronym / sponsor ID
- EPOetCEC / DCIC 05 04
- Conditions
- Myocardial Ischemia
- Keywords
- troponin T, CK-MB, protein S-100, Cardiopulmonary Bypass, Erythropoietin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jan 2006 (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 main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.
Detailed description
A new property of erythropoietin (EPO), independent of its hematopoietic role, has recently been discovered. Indeed, it has been reported that this hormone, following binding to its cardiac or cerebral receptors, is able to induce a spectacular cellular protection against ischemic injury. These cardioprotective and neuroprotective effects have been observed experimentally in rodents as well as clinically in humans. In particular, our team has demonstrated that the administration of NeoRecormon® protects the heart against ischemia in the rat by significantly improving its recovery.
In view of these exciting experimental results and of the growing interest of the scientific community for cytoprotective effects of EPO, we are planning the first clinical study examining the cardiac and cerebral protective effects of EPO (NeoRecormon®) in the setting of cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: epoetin betaepoetin beta |
| 2 | Placebo comparator | Drug: placeboplacebo of NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary bypass surgery.
- Surgery not urgent.
- Left ventricular ejection fraction (LVEF) > 40.
- Informed consent form signed.
Key exclusion criteria (15 listed)
- Valvular surgery.
- Surgery with beating heart, with or without cardiopulmonary bypass.
- Carotid bypass surgery.
- Myocardial infarction less than 30 days.
- Previous history of cardiac surgery.
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 |
|---|---|---|
| epoetin beta800UI/kg in 60ml of Nacl IV slow 1 to 3 hours before surgery | Drug | 1 |
| placebo60ml of NaCl IV slow | Drug | 2 |
Primary outcome
Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass
Time frame: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass
2 secondary outcomes
Area under curve and maximal plasmatic level of protein S-100 after cardiopulmonary bypass
Time frame: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass
Blood level of erythropoietin
Time frame: at injection and 6 hours after the end of cardiopulmonary bypass
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 7 Dec 2009.
- Background: PubMed 15249178Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.
- Background: PubMed 12435860Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
- Background: PubMed 12537211Johnsson P, Backstrom M, Bergh C, Jonsson H, Luhrs C, Alling C. Increased S100B in blood after cardiac surgery is a powerful predictor of late mortality. Ann Thorac Surg. 2003 Jan;75(1):162-8. doi: 10.1016/s0003-4975(02)04318-7.
- Background: PubMed 16011730Joyeux-Faure M, Godin-Ribuot D, Ribuot C. Erythropoietin and myocardial protection: what's new? Fundam Clin Pharmacol. 2005 Aug;19(4):439-46. doi: 10.1111/j.1472-8206.2005.00347.x.
- Background: PubMed 15347604Kerbaul F, Giorgi R, Oddoze C, Collart F, Guidon C, Lejeune PJ, Villacorta J, Gouin F. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery. Br J Anaesth. 2004 Nov;93(5):639-44. doi: 10.1093/bja/aeh246. Epub 2004 Sep 3.
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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.
Olivier CHAVANON, Pr principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
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 epoetin beta in people with Myocardial Ischemia, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 15 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 7 Dec 2009. 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 France. 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. Some participants in this study may receive a placebo. 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?
Area under curve and maximal plasmatic level of troponin-T, NT-pro-BNP, and creatine kinase-MB (CK-MB) after cardiopulmonary bypass (time frame: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), puis 6 h, 12 h, 24 h et 48h after the end of the cardiopulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273767, which also lists 5 linked publications.
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 7 Dec 2009.