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Remote Ischemic Preconditioning in Primary PCI

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ClinicalTrials.gov Identifier: NCT00435266
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : February 17, 2009
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Remote ischemic preconditioning Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Remote Preconditioning in Primary Percutaneous Intervention of Acute ST Elevation Myocardial Infarction
Study Start Date : February 2007
Primary Completion Date : November 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Remote ischemic preconditioning
Procedure: Remote ischemic preconditioning
Inflation of blood pressure cuff 4 x 5 minutes during transportation to primary PCI
No Intervention: 2 Procedure: Remote ischemic preconditioning
Inflation of blood pressure cuff 4 x 5 minutes during transportation to primary PCI

Outcome Measures

Primary Outcome Measures :
  1. Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Final infarct size. [ Time Frame: 30 days ]
  2. Proportion of patients achieving ≥70% ST-resolution 90 minutes following pPCI [ Time Frame: 90 minutes ]
  3. Proportion of patients achieving spontaneous ST-resolution before pPCI [ Time Frame: Immediate ]
  4. Proportion of patients with increase in ST-elevation during pPCI. [ Time Frame: Immediate ]
  5. Time from first ECG to ≥70% ST-resolution (continuous parameter) [ Time Frame: Minutes ]
  6. Time from first wire to ≥70% ST-resolution (continuous parameter) [ Time Frame: Minutes ]
  7. ST resolution immediately after ending the procedure (evaluated in relation to ST elevation on ECG obtained just prior to the pPCI procedure). [ Time Frame: Minutes ]
  8. Prompt angiographic success: [ Time Frame: Immediate ]
  9. Corrected TIMI frame count (cTFC). [ Time Frame: Minutes ]
  10. TIMI flow measured immediately after ending the interventional procedure. [ Time Frame: Minutes ]
  11. Myocardial blush. [ Time Frame: Minutes ]
  12. Procedure duration. [ Time Frame: Minutes ]
  13. Total duration of hospitalisation. [ Time Frame: Days ]
  14. MACE after 30 days. [ Time Frame: 30 days ]
  15. TnT release - determined 90-102 hours after symptom onset. [ Time Frame: 90-102 hours ]
  16. Echocardiographic data (acute and after 1 month): [ Time Frame: 30 days ]
  17. WMI. [ Time Frame: 30 days ]
  18. Left ventricular ejection fraction (LVEF) (%): (EDV - ESV)/EDV. [ Time Frame: 30 days ]
  19. Myocardial scintigraphy data: [ Time Frame: 30 days ]
  20. Regional wall motion and regional thickening. [ Time Frame: 30 days ]
  21. Technical success. [ Time Frame: Immediate ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435266

Department of Cardiology, Aarhus University Hospital Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Falck, Denmark
Doctor's ambulance Services, Aarhus, Denmark
Royal Brompton & Harefield NHS Foundation Trust
The Hospital for Sick Children
Study Director: Torsten T Nielsem, MD Aarhus University Hospital
Principal Investigator: Hans Erik Bøtker, MD, PhD Aarhus University Hospital
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hans Erik Bøtker, MD. Ph.D., Professor, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00435266     History of Changes
Other Study ID Numbers: 95093546-1
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

Keywords provided by University of Aarhus:
myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases