CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00145119
First received: September 2, 2005
Last updated: January 20, 2014
Last verified: January 2014
  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: 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:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)


Enrollment: 312
Study Start Date: August 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  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):

ClinicalTrials.gov Identifier: NCT00145119     History of Changes
Other Study ID Numbers: Medtronic_BRC_CRM_001
Study First Received: September 2, 2005
Results First Received: December 2, 2013
Last Updated: January 20, 2014
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 April 17, 2014