Cardiovascular Screening for Family Members of People With Acute Coronary Disease

Cardiovascular Risk Factor Clinical Trial

Official title:

Cardiovascular Screening for Family Members of People With Acute Coronary Disease: A Patient-Initiated and Family-Oriented Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440645
• Other study ID #: Pending
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2020
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Coronary Artery Disease
• Coronary Disease

Intervention

Other:
• Family-oriented primary cardiovascular prevention
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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital / Lady Davis Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Effectiveness of the screening strategy	Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score	12 months of study recruitment