Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis
NCT ID: NCT01330602
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1310 participants
INTERVENTIONAL
2010-05-31
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
An outcome-based study would require large numbers and would be unlikely to be funded without proof of concept. CIMT will be used as a validated surrogate of atherosclerotic status and future cardiovascular events in this study.
As such, this study will use CIMT (as both a delineator of risk and in the primary endpoint), a marker of atherosclerotic burden (the disease process rather than a surrogate), to address the unresolved issue about how to most efficiently manage intermediate risk subjects with a family history of premature atherosclerosis by combining better selection of such individuals for active treatment and recommended lifestyle changes with a DMP strategy to optimise their successful application in the longer-term.
The Intima-Media thickness guidance of Primary prevention in Relatives of individuals with Early onSet atherosclerosiS (IMPRESS) Study will test the following null hypothesis:
In intermediate risk, first-degree relatives (i.e. mother, father, brother or sister) of individuals with premature atherosclerosis, a CIMT-targeted DMP for primary prevention (the IMPRESS intervention) incorporating more intensive non-pharmacological and pharmacological management, provides no better reduction of atherosclerotic burden (as determined by the change in CIMT from baseline to follow-up completion) than usual health care management during three years follow-up.
Study Design The study hypotheses will be examined via a randomised controlled primary prevention/intervention trial comparing an individualised DMP with usual clinical care of middle-aged (40-65 years old) subjects who have a family history of premature cardiovascular disease and are determined to be at intermediate risk for a cardiovascular event within the next 5 years7, 22.
Study Centres
As a multicentre study, participants will be recruited from three centres:
* Princess Alexandra Hospital (Brisbane, Australia): responsible site investigator Associate Professor Karam Kostner
* Baker IDI Heart and Diabetes Institute/ The Alfred Hospital (Melbourne, Australia): responsible site investigator Dr Melinda Carrington
* National University Health System and Novena Heart Centre (Singapore): responsible site investigator Professor Desley Hegney
Participants This study will be conducted in a group of 40-65 year old adults.
IMPRESS Study will test the following null hypothesis:
In intermediate risk, first-degree relatives (i.e. mother, father, brother or sister) of individuals with premature atherosclerosis, a CIMT-targeted DMP for primary prevention (the IMPRESS intervention) incorporating more intensive non-pharmacological and pharmacological management, provides no better reduction of atherosclerotic burden (as determined by the change in CIMT from baseline to follow-up completion) than usual health care management during three years follow-up.
Primary End-Point Consistent with the study hypothesis, the primary study end-point is change in CIMT from baseline to three years, as determined by a blinded core laboratory and analysed on an intention-to-treat basis according to random study group allocation.
Secondary End-Points
The secondary endpoints are change from baseline to three years in the following variables:
i) Plaque length (carotid artery) ii) Internal CIMT iii) General health and well being (as measured by the SF-12 18 and EQ-5D 19) iv) Mental health (as determined by the Arrol 20 +/- CESD 21) v) Health care costs vi) Modifiable risk factors for atherosclerotic disease other than diabetes ( i.e. smoking, dyslipidaemia, obesity and hypertension) vii) Absolute cardiovascular risk profile 22 and risk of diabetes (as determined by the Type 2 Diabetes Risk Assessment Tool \[AUSDRISK\]) Score 23) viii) Diabetic status (as determined by fasting glucose) ix) All-cause mortality/ cardiovascular hospitalisation
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lifestyle counseling
All participants randomised into the IMPRESS Intervention group will undergo tailored health profiling.This individual assessment will be carried out within the clinic setting.
The key elements of the IMPRESS intervention include:
* Promoting a healthy lifestyle
* Supporting lifestyle and risk modification
* Encouraging active self-management of risk and chronic disease
* Improving coordination of care
* Pharmacological therapy All the individuals in the intervention group will receive a comprehensive report on their risk status and ideal goals.
IMPRESS intervention
The key elements of the IMPRESS intervention include:
* Promoting a healthy lifestyle
* Supporting lifestyle and risk modification
* Encouraging active self-management of risk and chronic disease
* Improving coordination of care
* Pharmacological therapy
Usual care arm
Usual Care Following the assessment of absolute cardiovascular risk, usual care participants will be provided a report outlining areas in which improvements could be made for the prevention of atherosclerotic burden.
No restrictions will be made in respect to usual care management. As such, the prescription of standard medications for primary prevention of atherosclerotic burden based on individual risk factors is anticipated in 20-30% of usual care participants.
At 18 months and three years those in the usual care arm will be invited to undergo repeat CIMT measurements, pathology, absolute risk score calculation and health-related questionnaires as part of the structured study follow-up
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IMPRESS intervention
The key elements of the IMPRESS intervention include:
* Promoting a healthy lifestyle
* Supporting lifestyle and risk modification
* Encouraging active self-management of risk and chronic disease
* Improving coordination of care
* Pharmacological therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are classified as "intermediate risk" of experiencing a cardiovascular event in the next 5 years as determined via the Framingham Risk Equation 7, 22
* Live within a geographically accessible area for follow-up (i.e. within a 40km radius of the study centre)
* Are living independently in the community or their own home
* Are able and willing to provide written informed consent to participate in the study (this includes the ability to understand and speak English fluently and that the patient is mentally competent)
Exclusion Criteria
* Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* Have contraindications to the use of statin medications (includes pregnancy and breastfeeding)
* Unable to provide written informed consent to participate in this study
* Have a terminal malignancy requiring palliative care, or limited life expectancy or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
* Participating in another clinical research trial
40 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Singapore
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Desley G HEGNEY, Professor
Role: PRINCIPAL_INVESTIGATOR
National University Health system, NUS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National University Hospital
Singapore, , Singapore
Novena heart Centre
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ling L Hsi, Assoc Prof
Role: primary
Raymond Lee, Dr
Role: primary
Poh Shuan Daniel Yeo, MBBS,MRCP(UK),FRCP(Edin),FACC
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSRB-C/10/005
Identifier Type: -
Identifier Source: org_study_id