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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure
• Intervention / Treatment: Procedure: Coronary angiography

• Study Type: Observational
• Enrollment (Actual): 2994

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients in Ontario, Canada with acute heart failure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause hospital readmission	Readmissions for all causes after 14 days or hospital discharge in landmark analysis	2 years
Heart failure readmission	Readmissions for heart failure after 14 days or hospital discharge in landmark analysis	2 years
Readmission for myocardial infarction	Readmissions for myocardial infarction after 14 days or hospital discharge in landmark analysis	2 years
Rates of revascularization	Coronary revascularization with CABG surgery or PCI procedure	90 days

Collaborators and Investigators

• Sponsor: Institute for Clinical Evaluative Sciences
• Investigators: Principal Investigator: Douglas Lee, MD, PhD, ICES

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): March 31, 2015
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Coronary angiography; Heart failure; Myocardial infarction; Invasive strategy; Troponin
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No