Myocardial Ischemic Reperfusion InjuryNCT02984111
Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
A study testing normal saline and erythropoietin in people with Myocardial Ischemic Reperfusion Injury, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Ischemic Reperfusion Injury
- What is being tested?
- normal saline and erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteIran
- Study dates
- Jan 2016to Jun 2017
- Phase
- Interventional
- 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
- Revascularization requirement according to angiographic evidence
- Elective coronary artery bypass graft surgery
- First time coronary artery bypass graft surgery
- On-pump coronary artery bypass graft surgery
Who cannot join
- History of myocardial infarction in the past 3 months
- Previous myocardial trauma or major surgery in the past 3 months
- Cr>2mg/dl
- Receiving streptokinase or previous reperfusion treatments
- Erythropoietin intake in the recent 6 months
- Known thromboembolic disorder and malignant disease
Show all 9Show fewer
- Uncontrolled hypertension
- Polycythemia
- Previous valvular surgery
Trial locations and contacts
1 site in 1 country.
Iran1 site
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.
Tehran, 199873438
About this study
Official title: Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
The aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response.
Read the detailed description
In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor.
Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. Activation of EPO receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms.
Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.It is associated with inflammation, cell injury and attenuate contractility property.
Although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. EPO intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .
- Conditions
- Myocardial Ischemic Reperfusion Injury
- Being tested
- normal saline, erythropoietin
- Keywords
- Coronary artery bypass, Erythropoietin, Inflammation, IL-6, Reperfusion injury, YKL- 40
- Medical subject headings
- Myocardial Reperfusion Injury, Inflammation, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Also called N/S
erythropoietinDrug
Also called epoietin alfa
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes Receives: Drug: erythropoietin |
| group B | Active comparator | 20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes Receives: Drug: erythropoietin |
| control | Placebo comparator | 50 ml normal saline infusion during aortic cross clamp in 45-60 minutes Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin 6(IL6)
Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Measured: Change from baseline until 48 hours after surgery
Change in YKL-40
Chitinase-3-like protein 1 (CHI3L1), also known as YKL-40 is an inflammatory marker.Serum YKL-40 level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Measured: Change from baseline until 48 hours after surgery
Change in pro b-type natriuretic peptide(pro BNP)
Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Measured: Change from baseline until 48 hours after surgery
Secondary outcomes (3)
Volume of bleeding
Measured: During operation until 24 hours after surgery
Need to blood transfusion
Number of packed cell and fresh frozen plasma that transfused in the period of time that patient is hospitalized.
Measured: During and after operation, through study completion,an average of one week
Ventilation time
Measured: Period of time after surgery that patient has been intubated in ICU,an average of 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Myocardial Ischemic Reperfusion InjuryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pooyesh Darou
- Responsible party
- Principal investigator, Mahnoosh Foroughi, Shahid Beheshti University of Medical Sciences
- Investigators
- Mahnoosh Foroughi, MD,, Principal investigator, Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences. Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984111
- Sponsor's protocol ID
- IR.sbmu.ram.rec.1394.292
- Other IDs
- IRCT2016011621087N1
- Status last verified
- Oct 2017
- First submitted
- 13 Nov 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ziabakhsh-Tabary S, Jalalian R, Mokhtari-Esbuie F, Habibi MR. Echocardiographic Evaluation of the Effects of a Single Bolus of Erythropoietin on Reducing Ischemia-Reperfusion Injuries during Coronary Artery Bypass Graft Surgery; A Randomized, Double-Blind, Placebo-Control Study. Iran J Med Sci. 2014 Mar;39(2):94-101.
PubMed 24644377Ludman AJ, Yellon DM, Hasleton J, Ariti C, Babu GG, Boston-Griffiths E, Venugopal V, Walker M, Holdright D, Swanton H, Crake T, Brull D, Moon JC, Puranik R, Muthurangu V, Taylor A, Hausenloy DJ. Effect of erythropoietin as an adjunct to primary percutaneous coronary intervention: a randomised controlled clinical trial. Heart. 2011 Oct;97(19):1560-5. doi: 10.1136/hrt.2011.223867.
PubMed 21900585Joyeux-Faure M, Durand M, Bedague D, Protar D, Incagnoli P, Paris A, Ribuot C, Levy P, Chavanon O. Evaluation of the effect of one large dose of erythropoietin against cardiac and cerebral ischemic injury occurring during cardiac surgery with cardiopulmonary bypass: a randomized double-blind placebo-controlled pilot study. Fundam Clin Pharmacol. 2012 Dec;26(6):761-70. doi: 10.1111/j.1472-8206.2011.00992.x. Epub 2011 Sep 20.
PubMed 21929528Najjar SS, Rao SV, Melloni C, Raman SV, Povsic TJ, Melton L, Barsness GW, Prather K, Heitner JF, Kilaru R, Gruberg L, Hasselblad V, Greenbaum AB, Patel M, Kim RJ, Talan M, Ferrucci L, Longo DL, Lakatta EG, Harrington RA; REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA. 2011 May 11;305(18):1863-72. doi: 10.1001/jama.2011.592.
PubMed 21558517Ott I, Schulz S, Mehilli J, Fichtner S, Hadamitzky M, Hoppe K, Ibrahim T, Martinoff S, Massberg S, Laugwitz KL, Dirschinger J, Schwaiger M, Kastrati A, Schmig A; REVIVAL-3 Study Investigators. Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial. Circ Cardiovasc Interv. 2010 Oct;3(5):408-13. doi: 10.1161/CIRCINTERVENTIONS.109.904425. Epub 2010 Aug 24.
PubMed 20736448Vilarinho KA, de Oliveira PP, Saad MJ, Eghtesady P, Filho LM, Vieira RW, Petrucci O. Erythropoietin protects the systolic function of neonatal hearts against ischaemia/reperfusion injury. Eur J Cardiothorac Surg. 2013 Jan;43(1):156-62. doi: 10.1093/ejcts/ezs254. Epub 2012 May 7.
PubMed 22564802Watson AJ, Gao L, Sun L, Tsun J, Jabbour A, Ru Qiu M, Jansz PC, Hicks M, Macdonald PS. Enhanced preservation of the rat heart after prolonged hypothermic ischemia with erythropoietin-supplemented Celsior solution. J Heart Lung Transplant. 2013 Jun;32(6):633-40. doi: 10.1016/j.healun.2013.03.014.
PubMed 23701853Lu MJ, Chen YS, Huang HS, Ma MC. Erythropoietin alleviates post-ischemic injury of rat hearts by attenuating nitrosative stress. Life Sci. 2012 May 22;90(19-20):776-84. doi: 10.1016/j.lfs.2012.04.012. Epub 2012 Apr 12.
PubMed 22521289Xu X, Cao Z, Cao B, Li J, Guo L, Que L, Ha T, Chen Q, Li C, Li Y. Carbamylated erythropoietin protects the myocardium from acute ischemia/reperfusion injury through a PI3K/Akt-dependent mechanism. Surgery. 2009 Sep;146(3):506-14. doi: 10.1016/j.surg.2009.03.022. Epub 2009 Jun 9.
PubMed 19715808Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.
PubMed 22305837Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.
PubMed 20802250Momeni M, Liistro G, Baele P, Matta A, Kahn D, Van Dyck M, De Kock M, De Kerchove L, Glineur D, Thiry D, Gregoire A, Jacquet LM, Laarbui F, Watremez C. An increase in endogenous erythropoietin concentrations has no cardioprotective effects in patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):251-7. doi: 10.1053/j.jvca.2011.07.034. Epub 2011 Oct 5.
PubMed 21975293Taniguchi N, Nakamura T, Sawada T, Matsubara K, Furukawa K, Hadase M, Nakahara Y, Nakamura T, Matsubara H. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study. Circ J. 2010 Nov;74(11):2365-71. doi: 10.1253/circj.cj-10-0267. Epub 2010 Sep 8.
PubMed 20834185Bergmann MW, Haufe S, von Knobelsdorff-Brenkenhoff F, Mehling H, Wassmuth R, Munch I, Busjahn A, Schulz-Menger J, Jordan J, Luft FC, Dietz R. A pilot study of chronic, low-dose epoetin-beta following percutaneous coronary intervention suggests safety, feasibility, and efficacy in patients with symptomatic ischaemic heart failure. Eur J Heart Fail. 2011 May;13(5):560-8. doi: 10.1093/eurjhf/hfr002.
PubMed 21505058Ferrario M, Arbustini E, Massa M, Rosti V, Marziliano N, Raineri C, Campanelli R, Bertoletti A, De Ferrari GM, Klersy C, Angoli L, Bramucci E, Marinoni B, Ferlini M, Moretti E, Raisaro A, Repetto A, Schwartz PJ, Tavazzi L. High-dose erythropoietin in patients with acute myocardial infarction: a pilot, randomised, placebo-controlled study. Int J Cardiol. 2011 Feb 17;147(1):124-31. doi: 10.1016/j.ijcard.2009.10.028. Epub 2009 Nov 10.
PubMed 19906454
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT02984111
- Acronym / sponsor ID
- IR.sbmu.ram.rec.1394.292
- Conditions
- Myocardial Ischemic Reperfusion Injury
- Keywords
- Coronary artery bypass, Erythropoietin, Inflammation, IL-6, Reperfusion injury, YKL- 40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Pooyesh Darou
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Dec 2016 (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 aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response.
Detailed description
In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor.
Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. Activation of EPO receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms.
Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.It is associated with inflammation, cell injury and attenuate contractility property.
Although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. EPO intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: erythropoietin20000 IU erythropoietin infusion during aortic cross clamp in 45-60 minutes |
| group B | Active comparator | Drug: erythropoietin20000 IU erythropoietin infusion after induction of anesthesia and before undergoing cardiopulmonary bypass pump in 45-60 minutes |
| control | Placebo comparator | Drug: normal saline50 ml normal saline infusion during aortic cross clamp in 45-60 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Revascularization requirement according to angiographic evidence
- Elective coronary artery bypass graft surgery
- First time coronary artery bypass graft surgery
- On-pump coronary artery bypass graft surgery
Key exclusion criteria (9 listed)
- History of myocardial infarction in the past 3 months
- Previous myocardial trauma or major surgery in the past 3 months
- Cr>2mg/dl
- Receiving streptokinase or previous reperfusion treatments
- Erythropoietin intake in the recent 6 months
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 |
|---|---|---|
| normal salineAlso: N/S | Drug | control |
| erythropoietinAlso: epoietin alfa | Drug | group A, group B |
Primary outcome
Change in Interleukin 6(IL6)
Time frame: Change from baseline until 48 hours after surgery
Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Change in YKL-40
Time frame: Change from baseline until 48 hours after surgery
Chitinase-3-like protein 1 (CHI3L1), also known as YKL-40 is an inflammatory marker.Serum YKL-40 level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
Change in pro b-type natriuretic peptide(pro BNP)
Time frame: Change from baseline until 48 hours after surgery
Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation
3 secondary outcomes
Volume of bleeding
Time frame: During operation until 24 hours after surgery
Need to blood transfusion
Time frame: During and after operation, through study completion,an average of one week
Ventilation time
Time frame: Period of time after surgery that patient has been intubated in ICU,an average of 10 hours
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 24 Oct 2017.
- Background: PubMed 24644377Ziabakhsh-Tabary S, Jalalian R, Mokhtari-Esbuie F, Habibi MR. Echocardiographic Evaluation of the Effects of a Single Bolus of Erythropoietin on Reducing Ischemia-Reperfusion Injuries during Coronary Artery Bypass Graft Surgery; A Randomized, Double-Blind, Placebo-Control Study. Iran J Med Sci. 2014 Mar;39(2):94-101.
- Background: PubMed 21900585Ludman AJ, Yellon DM, Hasleton J, Ariti C, Babu GG, Boston-Griffiths E, Venugopal V, Walker M, Holdright D, Swanton H, Crake T, Brull D, Moon JC, Puranik R, Muthurangu V, Taylor A, Hausenloy DJ. Effect of erythropoietin as an adjunct to primary percutaneous coronary intervention: a randomised controlled clinical trial. Heart. 2011 Oct;97(19):1560-5. doi: 10.1136/hrt.2011.223867.
- Background: PubMed 21929528Joyeux-Faure M, Durand M, Bedague D, Protar D, Incagnoli P, Paris A, Ribuot C, Levy P, Chavanon O. Evaluation of the effect of one large dose of erythropoietin against cardiac and cerebral ischemic injury occurring during cardiac surgery with cardiopulmonary bypass: a randomized double-blind placebo-controlled pilot study. Fundam Clin Pharmacol. 2012 Dec;26(6):761-70. doi: 10.1111/j.1472-8206.2011.00992.x. Epub 2011 Sep 20.
- Background: PubMed 21558517Najjar SS, Rao SV, Melloni C, Raman SV, Povsic TJ, Melton L, Barsness GW, Prather K, Heitner JF, Kilaru R, Gruberg L, Hasselblad V, Greenbaum AB, Patel M, Kim RJ, Talan M, Ferrucci L, Longo DL, Lakatta EG, Harrington RA; REVEAL Investigators. Intravenous erythropoietin in patients with ST-segment elevation myocardial infarction: REVEAL: a randomized controlled trial. JAMA. 2011 May 11;305(18):1863-72. doi: 10.1001/jama.2011.592.
- Background: PubMed 20736448Ott I, Schulz S, Mehilli J, Fichtner S, Hadamitzky M, Hoppe K, Ibrahim T, Martinoff S, Massberg S, Laugwitz KL, Dirschinger J, Schwaiger M, Kastrati A, Schmig A; REVIVAL-3 Study Investigators. Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial. Circ Cardiovasc Interv. 2010 Oct;3(5):408-13. doi: 10.1161/CIRCINTERVENTIONS.109.904425. Epub 2010 Aug 24.
- Results publication: PubMed 22564802Vilarinho KA, de Oliveira PP, Saad MJ, Eghtesady P, Filho LM, Vieira RW, Petrucci O. Erythropoietin protects the systolic function of neonatal hearts against ischaemia/reperfusion injury. Eur J Cardiothorac Surg. 2013 Jan;43(1):156-62. doi: 10.1093/ejcts/ezs254. Epub 2012 May 7.
- Results publication: PubMed 23701853Watson AJ, Gao L, Sun L, Tsun J, Jabbour A, Ru Qiu M, Jansz PC, Hicks M, Macdonald PS. Enhanced preservation of the rat heart after prolonged hypothermic ischemia with erythropoietin-supplemented Celsior solution. J Heart Lung Transplant. 2013 Jun;32(6):633-40. doi: 10.1016/j.healun.2013.03.014.
- Results publication: PubMed 22521289Lu MJ, Chen YS, Huang HS, Ma MC. Erythropoietin alleviates post-ischemic injury of rat hearts by attenuating nitrosative stress. Life Sci. 2012 May 22;90(19-20):776-84. doi: 10.1016/j.lfs.2012.04.012. Epub 2012 Apr 12.
- Results publication: PubMed 19715808Xu X, Cao Z, Cao B, Li J, Guo L, Que L, Ha T, Chen Q, Li C, Li Y. Carbamylated erythropoietin protects the myocardium from acute ischemia/reperfusion injury through a PI3K/Akt-dependent mechanism. Surgery. 2009 Sep;146(3):506-14. doi: 10.1016/j.surg.2009.03.022. Epub 2009 Jun 9.
- Results publication: PubMed 22305837Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.
- Results publication: PubMed 20802250Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.
- Results publication: PubMed 21975293Momeni M, Liistro G, Baele P, Matta A, Kahn D, Van Dyck M, De Kock M, De Kerchove L, Glineur D, Thiry D, Gregoire A, Jacquet LM, Laarbui F, Watremez C. An increase in endogenous erythropoietin concentrations has no cardioprotective effects in patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):251-7. doi: 10.1053/j.jvca.2011.07.034. Epub 2011 Oct 5.
- Individual participant dataSharing planned: No
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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.
Mahnoosh Foroughi, MD, principal investigator
Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences. Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline and erythropoietin in people with Myocardial Ischemic Reperfusion Injury, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 9 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 24 Oct 2017. 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 Iran. 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.
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?
Change in Interleukin 6(IL6) (time frame: Change from baseline until 48 hours after surgery). The study lists 3 primary outcomes in all. 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 NCT02984111, which also lists 18 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 24 Oct 2017.