Remote Ischemic Preconditioning in Primary PCI
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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 |
- Salvage index (% of left ventricle): Salvage / Area at Risk (AAR) by SPECT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
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 Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013