Invasive Coronary Angiography Early in Ischemic Heart Failure

Completed

• Conditions: Acute Heart Failure
• Interventions: Procedure: Coronary angiography

• Registration Number: NCT04245605
• Lead Sponsor: Institute for Clinical Evaluative Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-01
• Primary Completion: 2015-03-31
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Study Completion: 2021-09-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2994

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early angiography	Coronary angiography	Patients admitted to hospital with acute heart failure undergoing coronary angiography within 14 days of hospital admission

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	2 years	Death due to cardiovascular causes after 14 days in landmark analysis
All-cause mortality	2 years	Death from any cause after 14 days in landmark analysis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada