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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014