Cardiovascular Screening for Family Members of People With Acute Coronary Disease
Primary Purpose
Cardiovascular Risk Factor
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Family-oriented primary cardiovascular prevention
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Risk Factor
Eligibility Criteria
Inclusion Criteria:
- Patient age ≤70 years old admitted with an initial diagnosis of an acute coronary event (such as acute coronary syndrome or myocardial infarction)
- At least 1 first-degree family or household member age ≥ 18 years old
Exclusion Criteria
- No eligible family or household members
- Inability to contact family or household members
- Distance to study centre too far as determined by the patient
- Family or household members who have been screened for CV disease in the previous 2 years.
- Family or household members with known coronary disease.
Sites / Locations
- Jewish General Hospital / Lady Davis Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Family or Household Members
Arm Description
Outcomes
Primary Outcome Measures
Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit
The change in percentage of the mean modified Framingham cardiovascular risk score for family and household members between the initial visit and the 6-month follow-up visit
Secondary Outcome Measures
Effectiveness of the screening strategy
Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03440645
Brief Title
Cardiovascular Screening for Family Members of People With Acute Coronary Disease
Official Title
Cardiovascular Screening for Family Members of People With Acute Coronary Disease: A Patient-Initiated and Family-Oriented Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Over a 12-month period, patients admitted with acute coronary disease to the cardiovascular care unit at the Jewish General Hospital (JGH), an academic tertiary care referral center in Montreal, Quebec, will be approached to refer first-degree relatives and/or household members age 18 years or older to an outpatient cardiovascular (CV) risk factor screening and treatment program. Relatives and household members will undergo a focused history, physical, and CV risk factor assessment and will receive evidence-based guideline-recommended treatment as indicated. Participants will be referred to nutritionists, smoking cessation programs, and to other allied healthcare professionals as needed. A follow-up visit at 6-months will assess treatment adherence and improvement in CV risk factors. All family and/or household members including the index patient will be encouraged to attend all healthcare visits together.
The effectiveness of the screening strategy will be measured by the total number of participants identified as intermediate or high modified Framingham 10-year risk of cardiovascular disease. The effectiveness of the primary prevention intervention will be measured by the change in percentage of the mean modified Framingham 10-year risk score for participants between the initial visit and 6-month follow-up. The value of the referral, screening, and treatment program, as well as participant engagement and satisfaction will also be systematically evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family or Household Members
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Family-oriented primary cardiovascular prevention
Intervention Description
An initial screening visit including a targeted history, physical exam, and investigations as per the Canadian Cardiovascular Society's recommendations for cardiovascular primary prevention. Counselling and informational handouts on improved cardiovascular risk factor and lifestyle habits. All family and household members, as well as the cardiovascular disease proband, are encouraged to attend and participate in all healthcare visits.
Primary Outcome Measure Information:
Title
Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit
Description
The change in percentage of the mean modified Framingham cardiovascular risk score for family and household members between the initial visit and the 6-month follow-up visit
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effectiveness of the screening strategy
Description
Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score
Time Frame
12 months of study recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient age ≤70 years old admitted with an initial diagnosis of an acute coronary event (such as acute coronary syndrome or myocardial infarction)
At least 1 first-degree family or household member age ≥ 18 years old
Exclusion Criteria
No eligible family or household members
Inability to contact family or household members
Distance to study centre too far as determined by the patient
Family or household members who have been screened for CV disease in the previous 2 years.
Family or household members with known coronary disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goldfarb, MD
Organizational Affiliation
Lady Davis Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital / Lady Davis Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Screening for Family Members of People With Acute Coronary Disease
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