CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2005 by Medtronic Bakken Research Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Medtronic Bakken Research Center

ClinicalTrials.gov Identifier:

NCT00145119

First received: September 2, 2005

Last updated: November 8, 2005

Last verified: August 2005

History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Depression Heart Attack

U.S. FDA Resources

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

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gang UJ, Jøns C, Jørgensen RM, Abildstrøm SZ, Messier MD, Haarbo J, Huikuri HV, Thomsen PE. Clinical significance of late high-degree atrioventricular block in patients with left ventricular dysfunction after an acute myocardial infarction--a Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) substudy. Am Heart J. 2011 Sep;162(3):542-7. Epub 2011 Aug 11.

Jons C, Jacobsen UG, Joergensen RM, Olsen NT, Dixen U, Johannessen A, Huikuri H, Messier M, McNitt S, Thomsen PE; Cardiac Arrhythmias and Risk Stratification after Acute Myocardial Infarction (CARISMA) Study Group. The incidence and prognostic significance of new-onset atrial fibrillation in patients with acute myocardial infarction and left ventricular systolic dysfunction: a CARISMA substudy. Heart Rhythm. 2011 Mar;8(3):342-8. Epub 2010 Nov 18.

Bloch Thomsen PE, Jons C, Raatikainen MJ, Moerch Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Gang UJ, Hoest N, Boersma LV, Platou ES, Becker D, Messier MD, Huikuri HV; Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) Study Group. Long-term recording of cardiac arrhythmias with an implantable cardiac monitor in patients with reduced ejection fraction after acute myocardial infarction: the cardiac arrhythmias and risk stratification after acute myocardial infarction (CARISMA) study. Circulation. 2010 Sep 28;122(13):1258-64. Epub 2010 Sep 13.

Gang UJ, Jøns C, Jørgensen RM, Abildstrøm SZ, Haarbo J, Messier MD, Huikuri HV, Thomsen PE; CARISMA investigators. Heart rhythm at the time of death documented by an implantable loop recorder. Europace. 2010 Feb;12(2):254-60. Epub 2009 Dec 16.

Huikuri HV, Raatikainen MJ, Moerch-Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Hoest N, Boersma LV, Platou ES, Messier MD, Bloch-Thomsen PE; Cardiac Arrhythmias and Risk Stratification after Acute Myocardial Infarction study group. Prediction of fatal or near-fatal cardiac arrhythmia events in patients with depressed left ventricular function after an acute myocardial infarction. Eur Heart J. 2009 Mar;30(6):689-98. Epub 2009 Jan 20.

ClinicalTrials.gov Identifier:	NCT00145119 History of Changes
Other Study ID Numbers:	Medtronic_BRC_CRM_001
Study First Received:	September 2, 2005
Last Updated:	November 8, 2005
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

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases

Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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