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ICE-HF: Invasive Coronary Angiography Early in Ischemic Heart Failure

Sponsor
Institute for Clinical Evaluative Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT04245605
Collaborator
(none)
3,000
Enrollment
1
Location
129
Anticipated Duration (Months)
23.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Coronary angiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)
Actual Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Mar 31, 2015
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Early angiography

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

Procedure: Coronary angiography
Coronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure
Other Names:
  • Diagnostic coronary angiography

    		•
    Control

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

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [2 years]

      Death from any cause after 14 days in landmark analysis

    2. Cardiovascular mortality [2 years]

      Death due to cardiovascular causes after 14 days in landmark analysis

    Secondary Outcome Measures

    1. All-cause hospital readmission [2 years]

      Readmissions for all causes after 14 days or hospital discharge in landmark analysis

    2. Heart failure readmission [2 years]

      Readmissions for heart failure after 14 days or hospital discharge in landmark analysis

    3. Readmission for myocardial infarction [2 years]

      Readmissions for myocardial infarction after 14 days or hospital discharge in landmark analysis

    4. Rates of revascularization [90 days]

      Coronary revascularization with CABG surgery or PCI procedure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Adult patients with acute heart failure, hospitalized in Ontario, Canada, with evidence of possible ischemic heart disease, defined as at least one of: a) prior myocardial infarction, b) troponin elevation, or c) angina.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada

    Sponsors and Collaborators

    • Institute for Clinical Evaluative Sciences

    Investigators

    • Principal Investigator: Douglas Lee, MD, PhD, ICES

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Lee, Principal Investigator, Institute for Clinical Evaluative Sciences
    ClinicalTrials.gov Identifier:
    NCT04245605
    Other Study ID Numbers:
    • 3
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    Jan 31, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Douglas Lee, Principal Investigator, Institute for Clinical Evaluative Sciences
    Coronary angiography
    Invasive strategy
    Myocardial infarction
    Troponin
    Heart failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 31, 2020