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CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145119
First Posted: September 5, 2005
Last Update Posted: December 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Bakken Research Center
  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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: December 2, 2013
Results First Posted: January 17, 2014
Last Update Posted: December 1, 2015
Last Verified: January 2014

Keywords provided by Medtronic Bakken Research Center:
Acute myocardial infarction
Cardiac arrhythmias
Left ventricular dysfunction
Implantable loop recorder
Risk stratifiers

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Arrhythmias, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases