Clinical trial NCT04367220: Cardiovascular Imaging Registry of Canada
Official title: Cardiovascular Imaging Registry of Canada
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2020-04-29
Enrollment: 45000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* All patients referred for hospital-based cardiac imaging services

Exclusion Criteria:

* Failure or provide informed consent

Primary outcomes:
measure: Major adverse cardiovascular outcomes (MACE)
timeFrame: 2024
measure: Malignant arrhythmic events
timeFrame: 2024
measure: Heart failure events
timeFrame: 2024
measure: Atrial arrhythmic events
timeFrame: 2024
measure: All-cause mortality
timeFrame: 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Calgary
country: Canada
facility: Peter Lougheed Hospital
state: Alberta
city: Calgary
country: Canada
facility: Rockyview Hospital
state: Alberta
Study officials:
affiliation: Director of Stephenson Cardiac Imaging Centre
name: James White
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.