CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

This study is ongoing, but not recruiting participants.

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00145119

Purpose

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

Condition
Acute Myocardial Infarction

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Depression Heart Attack

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	Incidence and Prediction of Life-Threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction

Further study details as provided by Medtronic Bakken Research Center:

Estimated Enrollment:	300
Study Start Date:	August 2001
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145119

Locations

Netherlands
Medtronic Bakken Research Center B.V.
Maastricht, Netherlands

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Principal Investigator:	H. Huikuri, Prof.	Oulu University Central Hospital, Finland
Principal Investigator:	P. E. Bloch-Thomsen, Dr.	Gentofte University Hospital, Denmark

More Information

Study ID Numbers:	Medtronic_BRC_CRM_001
Study First Received:	September 2, 2005
Last Updated:	November 8, 2005
ClinicalTrials.gov Identifier:	NCT00145119
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Medtronic Bakken Research Center:

Acute myocardial infarction
Cardiac arrhythmias
Left ventricular dysfunction
Implantable loop recorder
Risk stratifiers

Study placed in the following topic categories:

Ventricular Dysfunction
Necrosis
Heart Diseases
Depression
Myocardial Ischemia
Vascular Diseases

Ventricular Dysfunction, Left
Ischemia
Infarction
Myocardial Infarction
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009