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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR1183
• Date of registration: 16/01/2008
• Primary sponsor: Leiden University Medical Center (LUMC), Department of Cardiology
• Public title: Effect of early biventricular pacing on long-term left ventricular remodeling in patients with acute myocardial infarction (RESCUE-MI).
• Scientific title: Effect of early biventricular pacing on long-term left ventricular remodeling in patients with acute myocardial infarction (RESCUE-MI). - RESCUE-MI
• Date of first enrolment: 1/2/2008
• Target sample size: 48
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1183
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: S.A. Mollema

• Name: S.A. Mollema

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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 µg/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 criteria: 1. Malignancy or other major co-morbidity;

2. Expected non-compliance to the study protocol.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Myocardial infarction

Intervention(s)

Open-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(s)

(Change in) LV end-systolic volume (LVESV) at 6 months follow-up.

Secondary Outcome(s)

Clinical status of patients at 6 months follow-up.

Secondary ID(s)

P07.222