NCT02399891

Brief Summary

Cohort study aimed at evaluating the incidence of left ventricular (LV) dysfunction after myocardial infraction (MI) and assessing the prognostic utility of change in ejection fraction (EF) over the initial 12 months after MI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

6 years

First QC Date

March 23, 2015

Last Update Submit

June 7, 2016

Conditions

Myocardial InfarctionDeathHeart Failure

Keywords

RemodelingPrognosisIncidenceQuality AssuranceEjection FractionSudden Death

Outcome Measures

Primary Outcomes (1)

  • Mortality

    2 years

Secondary Outcomes (2)

  • Ejection Fraction

    12 months

  • Heart Failure Hospitalization

    2 years

Study Arms (2)

Retrospective

MI prior to December 11, 2011

Other: Standard of Care

Prospective

MI on or after December 11, 2011

Other: Quality Assurance Implementation

Interventions

Quality Assurance ImplementationOTHER
Prospective
Standard of CareOTHER
Retrospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients surviving an acute MI.

You may qualify if:

  • confirmed MI

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T3H 4N4, Canada

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionDeathHeart FailureDeath, Sudden

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Derek V Exner, MD, MPH

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek S Chew, MD

CONTACT

4032203219dchew@ucalgary.ca

Rozsa Sas

CONTACT

4032107398rsas@ucalgary.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

December 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

CA(1)