NCT04367220

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2014Aug 2030

Study Start

First participant enrolled

August 1, 2014

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Expected
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 years

First QC Date

April 26, 2020

Last Update Submit

March 11, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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

Interventions

Patients with known or suspected cardiovascular disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients referred for hospital-based cardiac imaging services

You may not qualify if:

  • Failure or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

RECRUITING

South Health Campus

Calgary, Alberta, T3M1M4, Canada

RECRUITING

Peter Lougheed Hospital

Calgary, Alberta, Canada

RECRUITING

Rockyview Hospital

Calgary, Alberta, Canada

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • James White

    Director of Stephenson Cardiac Imaging Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCP(C) Director - Stephenson Cardiac Imaging Centre

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 29, 2020

Study Start

August 1, 2014

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2030

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations