Cardiovascular DiseasesCIROCNCT04367220
Cardiovascular Imaging Registry of Canada
An observational study of Cardiovascular Diseases, run by University of Calgary at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Diagnostic testing performed as per routine care
- How many people
- 45,000 participants
- Where
- 4 sitesCanada
- Study dates
- Aug 2014to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients referred for hospital-based cardiac imaging services
Who cannot join
- Failure or provide informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N2T9
James A White, MD
- Recruiting
South Health Campus
Calgary, Alberta, T3M1M4
James A White, MD
- Recruiting
Peter Lougheed Hospital
Calgary, Alberta
James A White, MD
- Recruiting
Rockyview Hospital
Calgary, Alberta
James A White, MD
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Diagnostic testing performed as per routine care
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testing performed as per routine careDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Diagnostic testing performed as per routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular outcomes (MACE)
Composite of all-cause death, heart failure admission, myocardial infarction, heart transplantation or LVAD, Stroke or TIA
Measured: 2024
Malignant arrhythmic events
Composite of sudden cardiac death or appropriate ICD shock
Measured: 2024
Heart failure events
Composite of heart failure admission, death or need for transplantation / LVAD
Measured: 2024
Atrial arrhythmic events
Occurrence of atrial fibrillation / atrial flutter (documented by 12-lead ECG or Holter monitor)
Measured: 2024
All-cause mortality
Death based on Vital Statistics Alberta and In-hospital coded death
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study startAug 2014
- Primary completionAug 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, James White, University of Calgary
- Investigators
- James White, Principal investigator, Director of Stephenson Cardiac Imaging Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367220
- Sponsor's protocol ID
- REB13-0902
- Acronym
- CIROC
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33722059
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Imaging Registry of Canada
- ClinicalTrials.gov ID
- NCT04367220
- Acronym / sponsor ID
- CIROC / REB13-0902
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with known or suspected cardiovascular disease | – | Diagnostic Test: Diagnostic testing performed as per routine careAll patients with known or suspected cardiovascular disease are studied with a-priori stratification of specific disease-based cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients referred for hospital-based cardiac imaging services
Key exclusion criteria (1 listed)
- Failure or provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testing performed as per routine care | Diagnostic test | Patients with known or suspected cardiovascular disease |
Primary outcome
Major adverse cardiovascular outcomes (MACE)
Time frame: 2024
Composite of all-cause death, heart failure admission, myocardial infarction, heart transplantation or LVAD, Stroke or TIA
Malignant arrhythmic events
Time frame: 2024
Composite of sudden cardiac death or appropriate ICD shock
Heart failure events
Time frame: 2024
Composite of heart failure admission, death or need for transplantation / LVAD
Atrial arrhythmic events
Time frame: 2024
Occurrence of atrial fibrillation / atrial flutter (documented by 12-lead ECG or Holter monitor)
All-cause mortality
Time frame: 2024
Death based on Vital Statistics Alberta and In-hospital coded death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 33722059Purmah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James White principal investigator
Director of Stephenson Cardiac Imaging Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Calgary at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James White (403-944-2805, jawhit@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular outcomes (MACE) (time frame: 2024). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.