NCT04245605

Brief Summary

To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,994

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

5 years

First QC Date

January 27, 2020

Last Update Submit

August 26, 2022

Conditions

Acute Heart Failure

Keywords

Coronary angiographyInvasive strategyMyocardial infarctionTroponinHeart failure

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    Death from any cause after 14 days in landmark analysis

    2 years

  • Cardiovascular mortality

    Death due to cardiovascular causes after 14 days in landmark analysis

    2 years

Secondary Outcomes (4)

  • All-cause hospital readmission

    2 years

  • Heart failure readmission

    2 years

  • Readmission for myocardial infarction

    2 years

  • Rates of revascularization

    90 days

Study Arms (2)

Early angiography

Patients admitted to hospital with acute heart failure undergoing coronary angiography within 14 days of hospital admission

Procedure: Coronary angiography

Control

Patients admitted to hospital with acute heart failure not undergoing coronary angiography within 14 days

Interventions

Coronary angiographyPROCEDURE

Coronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure

Also known as: Diagnostic coronary angiography
Early angiography

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-described male or female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients in Ontario, Canada with acute heart failure

You may not qualify if:

  • Recent myocardial infarction
  • Coronary angiogram or revascularization within previous 3 months before admission
  • Nonresidents of Ontario, invalid health card number
  • HF diagnosed after admission
  • Admission BNP or NT-proBNP not diagnostic of HF
  • Died within 14 days of admission
  • Palliative within 6 months prior to hospital admission
  • Elevated creatinine concentration
  • Documented anaphylactic contrast allergy
  • Ischemic or hemorrhagic stroke within 3 months prior to admission
  • Highest category of Hospital Frailty Risk Score
  • Active severe bleeding at time of hospital admission
  • Absolute platelet count \< 20
  • Metastatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Myocardial InfarctionHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Douglas Lee, MD, PhD

    ICES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

April 1, 2010

Primary Completion

March 31, 2015

Study Completion

September 30, 2021

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)