CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00145119
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Results First Submitted: 2013-12-02
• Results First Submitted QC: 2013-12-02
• Results First Posted: 2014-01-17
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Acute myocardial infarction (< 21 days)
• Ejection fraction <= 40 % or wall motion index <= 1.3

Exclusion Criteria

• Implantable loop recorder can't be implanted within 3 weeks after MI
• NYHA class IV
• Planned or previous ICD implantation
• Planned CABG
• Severe valvular disease
• Pregnancy
• Life expectancy < 1 year for non-cardiac cause

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)	2 year	ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

Trial Locations

Locations (1)

Medtronic Bakken Research Center B.V.; 🇳🇱 Maastricht, Netherlands