Cardiovascular Imaging Registry of Canada

Study Overview
=================
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.

Official Title
-----------------
Cardiovascular Imaging Registry of Canada

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic testing performed as per routine care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred for hospital-based cardiac imaging services Exclusion Criteria: Failure or provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with known or suspected cardiovascular disease<br>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<br> <br> |

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 |