Cardiovascular Screening for Family Members of People With Acute Coronary Disease

NCT03440645 | Completed

• 1 other identifier: Pending
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of the screening strategy

  12 months of study recruitment

Study Arms (1)

Family or Household Members

EXPERIMENTAL

Other: Family-oriented primary cardiovascular prevention

Interventions

Family-oriented primary cardiovascular prevention OTHER

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.

Family or Household Members

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

Location

Study Officials

• Michael Goldfarb, MD

  Lady Davis Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 22, 2018
• Study Start: January 9, 2018
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CA (1)