Cardiovascular Imaging Registry of Canada

Cardiovascular Diseases Clinical Trial

— CIROC  

Official title:

Cardiovascular Imaging Registry of Canada

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367220
• Other study ID #: REB13-0902
• Status: Recruiting
• Start date: August 2014
• Est. completion date: August 2030

Study information

• Verified date: March 2024
• Source: University of Calgary
• Contact: James White
• Phone: 403-944-2805
• Email: jawhit[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45000
• Est. completion date: August 2030
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients referred for hospital-based cardiac imaging services

Exclusion Criteria:

• Failure or provide informed consent

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Diagnostic Test:
• Diagnostic testing performed as per routine care

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Peter Lougheed Hospital	Calgary	Alberta
Canada	Rockyview Hospital	Calgary	Alberta
Canada	South Health Campus	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

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