Cardiovascular Screening for Family Members of People With Acute Coronary Disease

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Other: Family-oriented primary cardiovascular prevention

• Registration Number: NCT03440645
• Lead Sponsor: Lady Davis Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-04
• Study Start: 2018-01-09
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-22
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Family or Household Members	Family-oriented primary cardiovascular prevention	-

Primary Outcome Measures

Name	Time	Method
Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit	6 months	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

Name	Time	Method
Effectiveness of the screening strategy	12 months of study recruitment	Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score

Trial Locations

Locations (1)

Jewish General Hospital / Lady Davis Institute; 🇨🇦 Montréal, Quebec, Canada