Cardiovascular Risk FactorNCT03440645
Cardiovascular Screening for Family Members of People With Acute Coronary Disease
A study testing Family-oriented primary cardiovascular prevention in people with Cardiovascular Risk Factor, run by Lady Davis Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Family-oriented primary cardiovascular prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Jewish General Hospital / Lady Davis Institute
Montreal, Quebec, H3T 1E2
About this study
Official title: Cardiovascular Screening for Family Members of People With Acute Coronary Disease: A Patient-Initiated and Family-Oriented Strategy
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
- Being tested
- Family-oriented primary cardiovascular prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-oriented primary cardiovascular preventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Family or Household Members | Experimental | Not described Receives: Other: Family-oriented primary cardiovascular prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Effectiveness of the screening strategy
Total number of participants identified at intermediate or high risk on the modified Framingham CV risk score
Measured: 12 months of study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start9 Jan 2018
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
- Investigators
- Michael Goldfarb, MD, Principal investigator, Lady Davis Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440645
- Sponsor's protocol ID
- Pending
- Status last verified
- Oct 2020
- First submitted
- 4 Jan 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Screening for Family Members of People With Acute Coronary Disease: A Patient-Initiated and Family-Oriented Strategy
- ClinicalTrials.gov ID
- NCT03440645
- Acronym / sponsor ID
- Pending
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family or Household Members | Experimental | Other: Family-oriented primary cardiovascular prevention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-oriented primary cardiovascular preventionAn 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. | Other | Family or Household Members |
Primary outcome
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
1 secondary outcome
Effectiveness of the screening strategy
Time frame: 12 months of study recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Goldfarb, MD principal investigator
Lady Davis Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-oriented primary cardiovascular prevention in people with Cardiovascular Risk Factor, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean modified Framingham cardiovascular risk score from the initial visit to the 6 month follow-up visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.