CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

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

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Key information

Conditions

Acute Myocardial Infarction Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medtronic Bakken Research Center B.V.

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)

Time frame: 2 year

ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction

Important dates

Study start: 2001
Primary completion: 2007
Study completion: 2007
First posted: Sep 5, 2005
Registry last updated: Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed