NCT00399503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 14, 2016

Status Verified

November 1, 2006

Enrollment Period

6.3 years

First QC Date

November 13, 2006

Last Update Submit

June 13, 2016

Conditions

Myocardial InfarctionDeath, Sudden, CardiacDeath

Keywords

Noninvasive assessmentCombined parameterHolter

Interventions

Spectral T Wave AlternansPROCEDURE
Modified Moving Average T Wave AlternansPROCEDURE
Baroreceptor SensitivityPROCEDURE
Heart Rate VariabilityPROCEDURE
Heart Rate TurbulencePROCEDURE
Deceleration CapacityPROCEDURE
Signal Averaged ECGPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N4N1, Canada

Location

Related Publications (2)

  • 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. doi: 10.1016/j.jacc.2007.08.042. Epub 2007 Nov 26.

    PMID: 18068035RESULT

  • Slawnych MP, Nieminen T, Kahonen M, Kavanagh KM, Lehtimaki 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. doi: 10.1016/j.jacc.2008.12.026.

    PMID: 19324258DERIVED

MeSH Terms

Conditions

Myocardial InfarctionDeath, Sudden, CardiacDeath

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHeart ArrestDeath, Sudden

Study Officials

  • Derek V Exner, MD, MPH

    Libin Cardiovascular Institute of Alberta, University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 15, 2006

Study Start

September 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 14, 2016

Record last verified: 2006-11

Locations

CA(1)