Remote Ischemic Preconditioning in Primary PCI

NCT00435266 | Completed Phase 2

• 1 other identifier: 95093546-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Primary percutaneous coronary intervention (pPCI) is the preferred treatment in ST elevation myocardial infarction (STEMI). The infarct-related artery (IRA) can be opened in more than 90% of the patients. However, STEMI patients still end up with a persistent perfusion defect of highly variable magnitude indicating that adjunctive treatment may add further protection against tissue damage. Ischemic preconditioning (IPC) is an intervention by which myocardium threatened by ischemia is exposed to short and repeated sublethal ischemic episodes prior to sustained ischemia (local IPC). A systemic response with protection of more remote organs (remote IPC (rIPC)) also can be induced. We have recently found that the infarct reducing effect can be obtained by obstruction of an extremity even though the remote stimulus is initiated during sustained occlusion of a coronary artery, the so-called remote preconditioning (rPerC). The clinical perspective is now to examine if rPerC can reduce the infarct size in patients with unpredictable ischemia in ST elevation myocardial infarction (STEMI). We perform a randomized study where patients en route for pPCI are allocated to either rPerC or a standard treatment to evaluate whether the tissue damage can be reduced. Effect measure will be infarct size determined by scintigraphy (final infarct size and salvage).

Conditions

Myocardial Infarction

Keywords

myocardial infarction; remote; preconditioning; perconditioning; cardioprotection

Outcome Measures

Primary Outcomes (1)

• Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT

  30 days

Secondary Outcomes (21)

• Final infarct size.

  30 days

• Proportion of patients achieving ≥70% ST-resolution 90 minutes following pPCI

  90 minutes

• Proportion of patients achieving spontaneous ST-resolution before pPCI

  Immediate

• Proportion of patients with increase in ST-elevation during pPCI.

  Immediate

• Time from first ECG to ≥70% ST-resolution (continuous parameter)

  Minutes

Study Arms (2)

1

EXPERIMENTAL

Remote ischemic preconditioning

Procedure: Remote ischemic preconditioning

2

NO INTERVENTION

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioning PROCEDURE

Inflation of blood pressure cuff 4 x 5 minutes during transportation to primary PCI

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute chest pain or equivalent symptoms during \> 30 minutes.
• Duration of symptoms \< 12 hours.
• Cumulated ST elevation \> 2 mm in two contiguous leads.
• Age ≥ 18 years.
• Informed consent

You may not qualify if:

• Previous by-pass surgery.
• Pulseless femoral artery.
• Left bundle branch block in ECG (LBBB).
• Acute MI and/or treatment with thrombolysis within 30 days.
• Patients treated with cooling or patients who have had cardiac arrest.
• Diabetic patients
• Patients with arteriovenous shunts for the purpose of hemodialysis

Sponsors & Collaborators

• University of Aarhus: lead
• Falck, Denmark: collaborator
• Doctor's ambulance Services, Aarhus, Denmark: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

Department of Cardiology, Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (9)

• Schmidt MR, Smerup M, Konstantinov IE, Shimizu M, Li J, Cheung M, White PA, Kristiansen SB, Sorensen K, Dzavik V, Redington AN, Kharbanda RK. Intermittent peripheral tissue ischemia during coronary ischemia reduces myocardial infarction through a KATP-dependent mechanism: first demonstration of remote ischemic perconditioning. Am J Physiol Heart Circ Physiol. 2007 Apr;292(4):H1883-90. doi: 10.1152/ajpheart.00617.2006. Epub 2006 Dec 15.

  PMID: 17172279 RESULT

• Kristiansen SB, Henning O, Kharbanda RK, Nielsen-Kudsk JE, Schmidt MR, Redington AN, Nielsen TT, Botker HE. Remote preconditioning reduces ischemic injury in the explanted heart by a KATP channel-dependent mechanism. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1252-6. doi: 10.1152/ajpheart.00207.2004. Epub 2004 Oct 21.

  PMID: 15498829 RESULT

• Kristiansen SB, Lofgren B, Stottrup NB, Khatir D, Nielsen-Kudsk JE, Nielsen TT, Botker HE, Flyvbjerg A. Ischaemic preconditioning does not protect the heart in obese and lean animal models of type 2 diabetes. Diabetologia. 2004 Oct;47(10):1716-21. doi: 10.1007/s00125-004-1514-4. Epub 2004 Oct 7.

  PMID: 15480537 RESULT

• Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.

  PMID: 12460865 RESULT

• Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.

  PMID: 16750696 RESULT

• Pryds K, Bottcher M, Sloth AD, Munk K, Rahbek Schmidt M, Botker HE; CONDI Investigators. Influence of preinfarction angina and coronary collateral blood flow on the efficacy of remote ischaemic conditioning in patients with ST segment elevation myocardial infarction: post hoc subgroup analysis of a randomised controlled trial. BMJ Open. 2016 Nov 24;6(11):e013314. doi: 10.1136/bmjopen-2016-013314.

  PMID: 27884851 DERIVED

• Pryds K, Terkelsen CJ, Sloth AD, Munk K, Nielsen SS, Schmidt MR, Botker HE; CONDI Investigators. Remote ischaemic conditioning and healthcare system delay in patients with ST-segment elevation myocardial infarction. Heart. 2016 Jul 1;102(13):1023-8. doi: 10.1136/heartjnl-2015-308980. Epub 2016 Feb 24.

  PMID: 26911520 DERIVED

• Sloth AD, Schmidt MR, Munk K, Schmidt M, Pedersen L, Sorensen HT, Botker HE; CONDI Investigators. Impact of cardiovascular risk factors and medication use on the efficacy of remote ischaemic conditioning: post hoc subgroup analysis of a randomised controlled trial. BMJ Open. 2015 Apr 2;5(4):e006923. doi: 10.1136/bmjopen-2014-006923.

  PMID: 25838505 DERIVED

• Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

  PMID: 20189026 DERIVED

Related Links

• Aarhus University webpage

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Torsten T Nielsem, MD

  Aarhus University Hospital

  STUDY DIRECTOR

• Hans Erik Bøtker, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

DK (1)