Remote Ischemic Postconditioning in Humans
1 other identifier
interventional
266
1 country
1
Brief Summary
The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in humans. The minor myocardial damage associated with percutaneous revascularization procedures may be attenuated by producing controlled ischemia in the arms immediately after carrying out these procedures (remote ischemic post-conditioning). The justification and design of this clinical trial has been reported: Cardiology. 2011;119(3):164-9.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
January 21, 2015
CompletedJanuary 21, 2015
January 1, 2015
3 years
April 26, 2010
January 11, 2015
January 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Increase of Troponin at 24 Hours
24 hours
Secondary Outcomes (2)
Readmission Due to Acute Coronary Syndrome
12 month
Cardiovascular Mortality
12 month
Study Arms (2)
Remote postcondtioning
EXPERIMENTALPatients assigned to remote ischemic postconditioning (randomized controlled trial)
Control group
PLACEBO COMPARATORInterventions
Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
Eligibility Criteria
You may qualify if:
- Patients undergoing PCI due to stable angina
- Patients undergoing PCI due to unstable angina
You may not qualify if:
- Acute myocardial infarction during the previous two weeks
- Chronic renal failure with baseline creatinine above 3 mg/dL
- \. Collateral circulation of the revascularized artery (Rantrop \>0) 5. Prior treatment with glibenclamide. 6. Inability to receive follow-up, blood test or lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Related Publications (12)
JENNINGS RB, SOMMERS HM, SMYTH GA, FLACK HA, LINN H. Myocardial necrosis induced by temporary occlusion of a coronary artery in the dog. Arch Pathol. 1960 Jul;70:68-78. No abstract available.
PMID: 14407094BACKGROUNDYellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.
PMID: 17855673BACKGROUNDMurry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
PMID: 3769170BACKGROUNDJimenez-Navarro M, Gomez-Doblas JJ, Hernandez Garcia JM, Alonso-Briales J, Garcia Alcantara A, Gomez G, Rodriguez-Bailon I, de Teresa E. Does angina pectoris the week before protect against first acute myocardial infarction in patients with diabetes mellitus? Am J Cardiol. 2002 Jul 15;90(2):160-2. doi: 10.1016/s0002-9149(02)02442-6. No abstract available.
PMID: 12106849BACKGROUNDIliodromitis EK, Kyrzopoulos S, Paraskevaidis IA, Kolocassides KG, Adamopoulos S, Karavolias G, Kremastinos DT. Increased C reactive protein and cardiac enzyme levels after coronary stent implantation. Is there protection by remote ischaemic preconditioning? Heart. 2006 Dec;92(12):1821-6. doi: 10.1136/hrt.2006.089060. Epub 2006 Jul 19.
PMID: 16855045BACKGROUNDAli ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.
PMID: 17846333BACKGROUNDHausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PMID: 17707752BACKGROUNDHoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.
PMID: 19188504BACKGROUNDStaat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
PMID: 16186417BACKGROUNDAndreka G, Vertesaljai M, Szantho G, Font G, Piroth Z, Fontos G, Juhasz ED, Szekely L, Szelid Z, Turner MS, Ashrafian H, Frenneaux MP, Andreka P. Remote ischaemic postconditioning protects the heart during acute myocardial infarction in pigs. Heart. 2007 Jun;93(6):749-52. doi: 10.1136/hrt.2006.114504. Epub 2007 Apr 20.
PMID: 17449499BACKGROUNDGritsopoulos G, Iliodromitis EK, Zoga A, Farmakis D, Demerouti E, Papalois A, Paraskevaidis IA, Kremastinos DT. Remote postconditioning is more potent than classic postconditioning in reducing the infarct size in anesthetized rabbits. Cardiovasc Drugs Ther. 2009 Jun;23(3):193-8. doi: 10.1007/s10557-009-6168-5.
PMID: 19255833BACKGROUNDCarrasco-Chinchilla F, Munoz-Garcia AJ, Dominguez-Franco A, Millan-Vazquez G, Guerrero-Molina A, Ortiz-Garcia C, Enguix-Armada A, Alonso-Briales JH, Hernandez-Garcia JM, de Teresa-Galvan E, Jimenez-Navarro MF. Remote ischaemic postconditioning: does it protect against ischaemic damage in percutaneous coronary revascularisation? Randomised placebo-controlled clinical trial. Heart. 2013 Oct;99(19):1431-7. doi: 10.1136/heartjnl-2013-304172. Epub 2013 Jul 12.
PMID: 23850844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Manuel Jiménez Navarro
- Organization
- H Virgen de la Victoria
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel F Jiménez-Navarro, Doctor
Servicio Cardiología, Hospital Universitario Virgen de la Victoria
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 29, 2010
Study Start
February 1, 2009
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
January 21, 2015
Results First Posted
January 21, 2015
Record last verified: 2015-01