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Remote Ischemic Preconditioning in Primary PCI

NCT00435266 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-02-17

No results posted yet for this study

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

Interventions

PROCEDURE

Remote ischemic preconditioning

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

Sponsors & Collaborators

  • Falck, Denmark

    collaborator UNKNOWN

  • Doctor's ambulance Services, Aarhus, Denmark

    collaborator UNKNOWN

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Torsten T Nielsem, MD · Aarhus University Hospital

  • Hans Erik Bøtker, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-11-30
Completion
2009-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435266 on ClinicalTrials.gov