CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

May 9, 2018 updated by: Medtronic Bakken Research Center

Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)
Time Frame: 2 year
ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medtronic_BRC_CRM_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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