Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack - Full Text View

Sponsor:	University of Calgary
Collaborators:	Canadian Institutes of Health Research (CIHR) Heart and Stroke Foundation of Ontario Alberta Heritage Foundation for Medical Research GE Healthcare Cambridge Heart Inc. Hoffmann-La Roche
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00399503

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:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	Risk Estimation Following Infarction Noninvasive Evaluation (REFINE)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Cardiac Arrest Heart Attack

U.S. FDA Resources

Further study details as provided by University of Calgary:

Estimated Enrollment:	350
Study Start Date:	September 2001
Estimated Study Completion Date:	October 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
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

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 Ontario

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

No publications provided by University of Calgary

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Slawnych MP, Nieminen T, Kähönen M, Kavanagh KM, Lehtimäki T, Ramadan D, Viik J, Aggarwal SG, Lehtinen R, Ellis L, Nikus K, Exner DV; REFINE (Risk Estimation Following Infarction Noninvasive Evaluation); FINCAVAS (Finnish Cardiovascular Study) Investigators. Post-exercise assessment of cardiac repolarization alternans in patients with coronary artery disease using the modified moving average method. J Am Coll Cardiol. 2009 Mar 31;53(13):1130-7.

Exner DV, Kavanagh KM, Slawnych MP, Mitchell LB, Ramadan D, Aggarwal SG, Noullett C, Van Schaik A, Mitchell RT, Shibata MA, Gulamhussein S, McMeekin J, Tymchak W, Schnell G, Gillis AM, Sheldon RS, Fick GH, Duff HJ; REFINE Investigators. Noninvasive risk assessment early after a myocardial infarction the REFINE study. J Am Coll Cardiol. 2007 Dec 11;50(24):2275-84. Epub 2007 Nov 26.

Study ID Numbers:	CIHR 73-1518, HSFA 73-1220
Study First Received:	November 13, 2006
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00399503 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by University of Calgary:

Noninvasive assessment
Combined parameter
Holter

Additional relevant MeSH terms:

Death
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Heart Arrest
Ischemia
Necrosis

Pathologic Processes
Death, Sudden
Cardiovascular Diseases
Death, Sudden, Cardiac
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on November 20, 2009