Defibrillator After Primary Angioplasty randomised trial

Not Applicable

Completed

• Conditions: Cardiovascular; Circulatory System

• Registration Number: ISRCTN42195152
• Lead Sponsor: Individual Sponsor (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Study Completion: 2008-03-31
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

1. ST-elevation myocardial infarction treated with primary PCI within 30 days and 60 days before randomisation
2. At least one of the following criteria:
a. Thrombolysis In Myocardial Infarction (TIMI) flow after primary PCI less than three in the infarct related vessel
b. Left ventricular ejection lower than 30% as measured within four days after admission

Exclusion Criteria

1. Class I indication for ICD implantation
2. Documented previous myocardial infarction with Left Ventricular Ejection Fraction (LVEF) less than 30%
3. Age less than 18 years
4. Heart failure with New York Heart Association functional class IV
5. Inotropic medication within two weeks before randomisation
6. Mechanical tricuspid valve
7. Serious comorbidity such as cancer, with a high likelihood of death during the trial
8. Advanced cerebrovascular disease
9. Unwilling or unable to sign the consent form for participation
10. Females of childbearing age not using medically prescribed contraceptives

Study & Design

• Study Type: Interventional
• Study Design: Not specified