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Completed

NCT Number: NCT03440645

Cardiovascular Screening for Family Members of People With Acute Coronary Disease

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit

    Time frame: 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 outcomes

  1. Effectiveness of the screening strategy

    Time frame: 12 months of study recruitment

    Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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