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Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
GE Healthcare
Cambridge Heart Inc.
Hoffmann-La Roche
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00399503
First received: November 13, 2006
Last updated: June 13, 2016
Last verified: November 2006
  Purpose
This study evaluates the usefulness of noninvasive tests of the structure of the heart and the nervous system controlling the heart. It will assess whether combining tests that evaluate heart structure with others that measure the nervous system controlling the heart will identify most patients who develop serious heart rhythm problems after a heart attack.

Condition Intervention
Myocardial Infarction
Death, Sudden, Cardiac
Death
Procedure: Spectral T Wave Alternans
Procedure: Modified Moving Average T Wave Alternans
Procedure: Baroreceptor Sensitivity
Procedure: Heart Rate Variability
Procedure: Heart Rate Turbulence
Procedure: Deceleration Capacity
Procedure: Signal Averaged ECG

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Risk Estimation Following Infarction Noninvasive Evaluation (REFINE)

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Estimated Enrollment: 350
Study Start Date: September 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed MI <31 days, based upon elevated cardiac-specific CK (total CK-MB mass >7ng/mL or CK-MB/total CK ≥ 2.5%) or troponin-T (> 0.1 ng/ml)144) plus
  • clinical symptoms or ECG evidence of myocardial injury (ST deviation ≥ 1 mm in 2, contiguous leads or new/previously undocumented Q waves)144, &
  • left ventricular ejection fraction ≤ 0.40 within 48 hrs or ≤ 0.50 beyond 48 hrs of MI using (echocardiography, radionuclide or contrast angiography) &
  • Sinus rhythm at the time of enrollment.

Exclusion Criteria:

  • Geographic isolation or inability to return for follow-up,
  • Comorbid illness likely to cause death within 24 months,
  • Inability to complete a submaximal exercise test (e.g., urgent CABG),
  • Class I indication for a defibrillator (e.g., VF or sustained VT > 48 hours of index MI), or
  • Lack of written informed consent
  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: NCT00399503

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N4N1
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
GE Healthcare
Cambridge Heart Inc.
Hoffmann-La Roche
Investigators
Principal Investigator: Derek V Exner, MD, MPH Libin Cardiovascular Institute of Alberta, University of Calgary
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00399503     History of Changes
Other Study ID Numbers: CIHR 73-1518  HSFA 73-1220 
Study First Received: November 13, 2006
Last Updated: June 13, 2016
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Calgary:
Noninvasive assessment
Combined parameter
Holter

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

ClinicalTrials.gov processed this record on December 02, 2016