Cardiovascular Imaging Registry of Canada

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Diagnostic Test: Diagnostic testing performed as per routine care

• Registration Number: NCT04367220
• Lead Sponsor: University of Calgary

Brief Summary

A multi-site, multi-modality prospective observational clinical outcomes study focussed on the development of phenotype-dirven risk prediction modelling in patients with known or suspected cardiovascular disease.

Detailed Description

The Cardiovascular Imaging Registry of Canada (CIROC) was conceived to provide a common standardized architecture for the collection of clinically reported imaging biomarkers, demographic information, resource utilization and clinical outcomes among patients referred to non-invasive cardiac imaging. The Registry was designed to assess the feasibility of implementing personalized care strategies through automated high quality data collection and patient engagement.

The CIROC Registry was launched with inaugural focus on Cardiac MRI base phenotyping, however has evolved to encompass cardiac CTA and echocardiography. Clinically referred patients are engaged by automated, tablet-based tools to collect informed consent and deploy standardized patient health assessments. Standardized reporting of disease features are captured using bespoke reporting tools. All patients are prospectively followed for a period of 10-years using linkage to administrative health data, inclusive of ICD-coded events, laboratory test results, ECG and vital statistics.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45000

Inclusion Criteria

• All patients referred for hospital-based cardiac imaging services

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Exclusion Criteria

• Failure or provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with known or suspected cardiovascular disease	Diagnostic testing performed as per routine care	All patients with known or suspected cardiovascular disease are studied with a-priori stratification of specific disease-based cohorts.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	2024	Death based on Vital Statistics Alberta and In-hospital coded death
Malignant arrhythmic events	2024	Composite of sudden cardiac death or appropriate ICD shock
Heart failure events	2024	Composite of heart failure admission, death or need for transplantation / LVAD
Atrial arrhythmic events	2024	Occurrence of atrial fibrillation / atrial flutter (documented by 12-lead ECG or Holter monitor)
Major adverse cardiovascular outcomes (MACE)	2024	Composite of all-cause death, heart failure admission, myocardial infarction, heart transplantation or LVAD, Stroke or TIA

Trial Locations

Locations (4)

South Health Campus; 🇨🇦 Calgary, Alberta, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Peter Lougheed Hospital; 🇨🇦 Calgary, Alberta, Canada

Rockyview Hospital; 🇨🇦 Calgary, Alberta, Canada