|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Aarhus |
|---|---|
| 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 |
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 II Phase III |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Department of Cardiology, Aarhus University Hospital Skejby | |
| Aarhus N, Denmark, 8200 | |
| 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
| 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 |
|
myocardial infarction remote preconditioning perconditioning cardioprotection |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |