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Effect of early biventricular pacing on long-term left ventricular remodeling in patients with acute myocardial infarction (RESCUE-MI).


- candidate number3004
- NTR NumberNTR1183
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2008
- Secondary IDsP07.222 
- Public TitleEffect of early biventricular pacing on long-term left ventricular remodeling in patients with acute myocardial infarction (RESCUE-MI).
- Scientific TitleEffect of early biventricular pacing on long-term left ventricular remodeling in patients with acute myocardial infarction (RESCUE-MI).
- ACRONYMRESCUE-MI
- hypothesisLarge myocardial infarction (MI) often results in left ventricular (LV) remodelling which is associated with an adverse long-term prognosis. Early biventricular pacing after acute MI may attenuate LV remodeling and may thereby lead to better prognosis. The aim of this study is to assess the possibility of attenuating LV remodeling after large acute MI by early biventricular pacing.
- Healt Condition(s) or Problem(s) studiedMyocardial infarction
- Inclusion criteria1. Presentation with an acute MI;
2. Primary PCI as treatment for acute MI;
3. No history of ischemic heart disease;
4. Peak Troponin T >8 g/L within 24 hours after admission;
5. LV ejection fraction <45%;
6. LV dyssynchrony ≥130ms (assessed with speckle tracking analysis);
7. At least 18 years of age.
- Exclusion criteria1. Malignancy or other major co-morbidity;
2. Expected non-compliance to the study protocol.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-feb-2009
- Target number of participants48
- InterventionsOpen-label trial in which patients will be randomly assigned to one of two groups: optimal medical treatment plus a biventricular pacemaker with implantable cardioverter-defibrillator (biventricular ICD) device or optimal medical treatment alone.
- Primary outcome(Change in) LV end-systolic volume (LVESV) at 6 months follow-up.
- Secondary outcomeClinical status of patients at 6 months follow-up.
- Timepoints1. Baseline;
2. 6-Months follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. S.A. Mollema
- CONTACT for SCIENTIFIC QUERIESDrs. S.A. Mollema
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe aim of this study is to assess the possibility of attenuating LV remodeling after large acute MI by early biventricular pacing. Patients will be randomly assigned to one of two groups: optimal medical treatment plus a biventricular pacemaker with implantable cardioverter-defibrillator (biventricular ICD) device or optimal medical treatment alone. After 6 months follow-up the (change in) LV end-systolic volume (LVESV) and clinical status of patients will be assessed.
- Main changes (audit trail)
- RECORD16-jan-2008 - 17-apr-2008


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