Your session is about to expire
← Back to Search
Lipid Management Interventions for Cardiovascular Disease Risk
N/A
Recruiting
Led By Jacob A Udell, MD, MPH, FRCPC
Research Sponsored by Institute for Clinical Evaluative Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to increase the use of cholesterol-lowering statin drugs to prevent heart attack and stroke in high-risk health regions across Ontario using a 'toolbox' of interventions.
Who is the study for?
This trial is for communities in Ontario with higher-than-average cardiovascular disease rates, a certain number of family physicians, and specific population sizes of adults aged 40-75. It's not for patients who already have established heart conditions.
What is being tested?
The CHOICES study is testing how 'big data' can be used in clinical trials to improve cholesterol management using a toolbox of informational strategies aimed at both doctors and patients to prevent heart attacks and strokes.
What are the potential side effects?
Since the interventions involve informational strategies rather than medications or procedures, traditional side effects are not applicable. However, there may be indirect effects on healthcare practices within the community.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of 66 -75 year old patients who filled a statin prescription
Secondary study objectives
Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)
Incidence of Diabetes Mellitus (DM)
Cerebrovascular accident
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The 14 communities that are in the intervention arm of the trial will receive a multicomponent intervention that provides both physicians and patients with access to a 'toolbox' of lipid management resources. The components planned for the 'toolbox' are all evidence-based interventions and chosen after consultations with Canadian family physicians and implementation science experts based on their potential for scalability to the entire population, cost and practicality. Online tools will be used and the trial will leverage pre-existing implementation initiatives (e.g., newsletters, listservs) wherever possible to minimize study costs and increase accessibility.
Group II: Control ArmActive Control1 Intervention
The 14 communities that are in the control arm of the trial will receive usual standard of care. The usual standard of care will follow clinical daily practice patterns provided by family physicians in Ontario for CVD prevention. This follows the periodic standard of care provided by Canadian cholesterol, hypertension, and diabetes best practice guideline recommendations utilized based on each physician's clinical judgement, physical assessment, and discretion. Patients also typically have access to existing cardiovascular prevention materials offered online through publicly available websites.
Find a Location
Who is running the clinical trial?
Heart and Stroke Foundation of OntarioOTHER
66 Previous Clinical Trials
331,916 Total Patients Enrolled
1 Trials studying Cardiovascular Risk
200,000 Patients Enrolled for Cardiovascular Risk
Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular ResearchUNKNOWN
The Ontario Spor Support UnitOTHER
5 Previous Clinical Trials
8,174 Total Patients Enrolled
CorHealth OntarioOTHER
1 Previous Clinical Trials
54 Total Patients Enrolled
Knowledge Translation Program of St. Michael's HospitalUNKNOWN
Knowledge Translation Program at St. Michael's HospitalUNKNOWN
The Heart and Stroke FoundationUNKNOWN
Institute for Clinical Evaluative SciencesLead Sponsor
36 Previous Clinical Trials
2,009,001 Total Patients Enrolled
Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular ResearchUNKNOWN
Jacob A Udell, MD, MPH, FRCPCPrincipal InvestigatorICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto