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OpenTrials
Completed

NCT Number: NCT04245605

Invasive Coronary Angiography Early in Ischemic Heart Failure

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

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Key information

Conditions

Acute Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

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

Other names: Diagnostic coronary angiography

Primary outcomes

  1. All-cause mortality

    Time frame: 2 years

    Death from any cause after 14 days in landmark analysis

  2. Cardiovascular mortality

    Time frame: 2 years

    Death due to cardiovascular causes after 14 days in landmark analysis

Secondary outcomes

  1. All-cause hospital readmission

    Time frame: 2 years

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

  2. Heart failure readmission

    Time frame: 2 years

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

  3. Readmission for myocardial infarction

    Time frame: 2 years

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

  4. Rates of revascularization

    Time frame: 90 days

    Coronary revascularization with CABG surgery or PCI procedure

Sponsors and collaborators

Lead sponsor

Institute for Clinical Evaluative Sciences

Other

Registry information

Official study title

Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)

Acronym: ICE-HF

Important dates

Study start
2010
Primary completion
2015
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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