Remote Ischemic Postconditioning in Humans

NCT ID: NCT01113008

Last Updated: 2015-01-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Percutaneous coronary intervention (PCI) has taken on an important role in the treatment of ischemic heart disease in recent years. However, the beneficial effects of revascularization are partly shadowed by post-reperfusion injury, which accounts for up to half the size of the reperfused myocardial infarct. Several drugs and procedures exist that might protect against this phenomenon. One of the most controversial of these strategies, which has shown promising results in experimental animal models, is remote ischemic post-conditioning. This involves inducing ischemia at a site remote from the heart after an ischemic coronary lesion to reduce the resulting myocardial infarct size.

The myocardial damage produced by ischemia-reperfusion associated with PCI is a known short- and long-term prognostic factor, and is associated with a greater risk of death, myocardial infarction and revascularization during the follow-up.

Our aim is to assess the phenomenon of remote ischemic post-conditioning in patients undergoing PCI, in whom the acute insult on the myocardium is determined by the angioplasty itself. Additionally, we aim to evaluate this phenomenon in a subgroup of diabetic patients, among whom the effectiveness of protective measures against post-reperfusion damage is more questioned.

We have designed a randomized, single-blinded interventional study involving 320 patients (40% diabetics) who are to undergo elective PCI. At the end of the angioplasty procedure, the patients assigned to remote ischemic post-conditioning 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.

The infarct size will be analyzed from an enzyme curve of troponin I and CK-MB values 0, 8, 16 and 24 hours after the procedure (primary endpoint). Measurements will also be taken of pH and lactate in the baseline sample (0 hours) and at 8 hours, and ultrasensitive C-reactive protein at 0 and 24 hours as a contrasted marker of inflammation in ischemic heart disease.

The follow-up, planned for one year, will seek to determine clinically interesting variables (secondary endpoint), such as readmission due to acute coronary syndrome, heart failure or major arrhythmic events and overall and cardiovascular mortality.

Conditions

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Myocardial Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Remote postcondtioning

Patients assigned to remote ischemic postconditioning (randomized controlled trial)

Group Type EXPERIMENTAL

Remote ischemic postconditioning

Intervention Type PROCEDURE

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

Control group

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type PROCEDURE

In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.

Interventions

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Remote ischemic postconditioning

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

Intervention Type PROCEDURE

Control group

In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing PCI due to stable angina
2. Patients undergoing PCI due to unstable angina
3. Patients undergoing PCI due NON Q acute myocardial infarction with normal troponin at inclusion moment (less than 1 ng/ml)

Exclusion Criteria

1. Acute myocardial infarction during the previous two weeks
2. Chronic renal failure with baseline creatinine above 3 mg/dL

4\. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FUNDACIÓN IMABIS

UNKNOWN

Sponsor Role collaborator

Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Virgen de la Victoria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel F Jiménez-Navarro, Doctor

Role: PRINCIPAL_INVESTIGATOR

Servicio Cardiología, Hospital Universitario Virgen de la Victoria

Locations

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Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 14407094 (View on PubMed)

Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.

Reference Type BACKGROUND
PMID: 17855673 (View on PubMed)

Murry 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.

Reference Type BACKGROUND
PMID: 3769170 (View on PubMed)

Jimenez-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.

Reference Type BACKGROUND
PMID: 12106849 (View on PubMed)

Iliodromitis 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.

Reference Type BACKGROUND
PMID: 16855045 (View on PubMed)

Ali 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.

Reference Type BACKGROUND
PMID: 17846333 (View on PubMed)

Hausenloy 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.

Reference Type BACKGROUND
PMID: 17707752 (View on PubMed)

Hoole 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.

Reference Type BACKGROUND
PMID: 19188504 (View on PubMed)

Staat 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.

Reference Type BACKGROUND
PMID: 16186417 (View on PubMed)

Andreka 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.

Reference Type BACKGROUND
PMID: 17449499 (View on PubMed)

Gritsopoulos 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.

Reference Type BACKGROUND
PMID: 19255833 (View on PubMed)

Carrasco-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.

Reference Type DERIVED
PMID: 23850844 (View on PubMed)

Other Identifiers

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PI-0327/2008

Identifier Type: -

Identifier Source: org_study_id

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