Remote Ischemic Preconditioning in Primary PCI

This study has been completed.
Sponsor:
Collaborators:
Falck, Denmark
Doctor's ambulance Services, Aarhus, Denmark
Royal Brompton & Harefield NHS Foundation Trust
The Hospital for Sick Children
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00435266
First received: February 13, 2007
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Myocardial Infarction
Procedure: Remote ischemic preconditioning
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Remote Preconditioning in Primary Percutaneous Intervention of Acute ST Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final infarct size. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of patients achieving ≥70% ST-resolution 90 minutes following pPCI [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Proportion of patients achieving spontaneous ST-resolution before pPCI [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Proportion of patients with increase in ST-elevation during pPCI. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Time from first ECG to ≥70% ST-resolution (continuous parameter) [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • Time from first wire to ≥70% ST-resolution (continuous parameter) [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Prompt angiographic success: [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Corrected TIMI frame count (cTFC). [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • TIMI flow measured immediately after ending the interventional procedure. [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • Myocardial blush. [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • Procedure duration. [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • Total duration of hospitalisation. [ Time Frame: Days ] [ Designated as safety issue: No ]
  • MACE after 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • TnT release - determined 90-102 hours after symptom onset. [ Time Frame: 90-102 hours ] [ Designated as safety issue: No ]
  • Echocardiographic data (acute and after 1 month): [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • WMI. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction (LVEF) (%): (EDV - ESV)/EDV. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Myocardial scintigraphy data: [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Regional wall motion and regional thickening. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Technical success. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435266

Locations
Denmark
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
Investigators
Study Director: Torsten T Nielsem, MD Department of Cardiology, Aarhus University Hospital Skejby
Principal Investigator: Hans Erik Bøtker, MD, PhD Department of Cardiology, Aarhus University Hospital Skejby
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: February 13, 2007
Last Updated: February 16, 2009
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
myocardial infarction
remote
preconditioning
perconditioning
cardioprotection

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

ClinicalTrials.gov processed this record on October 30, 2014