Clinical trial NCT03440645: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit
timeFrame: 6 months
Secondary outcomes:
measure: Effectiveness of the screening strategy
timeFrame: 12 months of study recruitment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital / Lady Davis Institute
state: Quebec
Study officials:
affiliation: Lady Davis Institute for Medical Research
name: Michael Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References: