Invasive Coronary Angiography Early in Ischemic Heart Failure

Acute Heart Failure Clinical Trial

— ICE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245605
• Other study ID #: 3
• Status: Completed
• Start date: April 1, 2010
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2022
• Source: Institute for Clinical Evaluative Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2994
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical Evaluative Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Death from any cause after 14 days in landmark analysis	2 years
Primary	Cardiovascular mortality	Death due to cardiovascular causes after 14 days in landmark analysis	2 years
Secondary	All-cause hospital readmission	Readmissions for all causes after 14 days or hospital discharge in landmark analysis	2 years
Secondary	Heart failure readmission	Readmissions for heart failure after 14 days or hospital discharge in landmark analysis	2 years
Secondary	Readmission for myocardial infarction	Readmissions for myocardial infarction after 14 days or hospital discharge in landmark analysis	2 years
Secondary	Rates of revascularization	Coronary revascularization with CABG surgery or PCI procedure	90 days