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

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ClinicalTrials.gov Identifier: NCT00399503
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : June 14, 2016
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

Brief Summary:
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 or disease Intervention/treatment
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

  Show Detailed Description

Study Type : Observational
Enrollment : 350 participants
Time Perspective: Prospective
Official Title: Risk Estimation Following Infarction Noninvasive Evaluation (REFINE)
Study Start Date : September 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources





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:

  • 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

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): 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

Publications of Results:
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
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: November 2006

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