Cardiovascular Imaging Registry of Canada (CIROC)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Diagnostic test: Diagnostic testing performed as per routine care

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 Type: Observational
• Enrollment (Estimated): 45000

Contacts and Locations

• Study Contact: Name: James White; Phone Number: 403-944-2805; Email: jawhit@ucalgary.ca
• Study Contact Backup: Name: Sandra Rivest; Phone Number: 403-944-1961; Email: sandra.rivest@ahs.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Peter Lougheed Hospital
      • Contact: James A White, MD
    • Calgary, Alberta, Canada, T3M1M4
      • Recruiting
      • South Health Campus
      • Contact: James A White, MD
    • Calgary, Alberta, Canada, T2N2T9
      • Recruiting
      • Foothills Medical Centre
      • Contact: James A White, MD
    • Calgary, Alberta, Canada
      • Recruiting
      • Rockyview Hospital
      • Contact: James A White, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for hospital based cardiac imaging services are considered eligible and are routinely approached using automated patient engagement tools and consent management services.

Description

Inclusion Criteria:

• All patients referred for hospital-based cardiac imaging services

Exclusion Criteria:

• Failure or provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: James White, Director of Stephenson Cardiac Imaging Centre

Publications and helpful links

General Publications

• Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REB13-0902

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