Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis (IMPRESS)
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Purpose
The primary objective of this study is, to instigate a reduction in atherosclerotic burden within the carotid arteries in the intervention group compared to the control group and to demonstrate parallel improvements in cardiovascular and overall health status relative to usual care
| Condition | Intervention |
|---|---|
|
Atherosclerotic Cardiovascular Disease Cardiovascular Disease |
Behavioral: IMPRESS intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis: The IMPRESS Study- A Multi-centre, Randomised Controlled Trial |
- Change in CIMT from baseline to three years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
- i) Plaque length (carotid artery) ii) Internal CIMT iii) General health and well being iv) Mental health v) Health care costs vi) Modifiable risk factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 1310 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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:
|
Behavioral: IMPRESS intervention
The key elements of the IMPRESS intervention include:
Other Names:
|
|
No Intervention: 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 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Have a first-degree relative (i.e. a mother, father, brother or sister) with premature (onset <65 years of age) atherosclerosis. This includes coronary artery disease/acute myocardial infarction, non-haemorrhagic stroke and peripheral vascular disease.
- 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:
- Pre-existing atherosclerotic disease
- 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
Contacts and Locations| Contact: Khong Y Tang, Ms | 65167456 | nurkyt@nus.edu.sg |
| Contact: Kee B Leng, Mdm | 65167456 | nurkblb@nus.edu.sg |
| Singapore | |
| National University Hospital | Recruiting |
| Singapore, Singapore, 119228 | |
| Contact: Ling L Hsi, Assoc Prof 67725283 mdcllh@nus.edu.sg | |
| Novena heart Centre | Recruiting |
| Singapore, Singapore, 307506 | |
| Contact: Raymond Lee, Dr 6397-2004 appt@novenaheartcentre.com.sg | |
| Principal Investigator: | Desley G HEGNEY, Professor | National University Health system, NUS |
More Information
No publications provided
| Responsible Party: | Professor Desley Gail HEGNEY, National University of Singapore |
| ClinicalTrials.gov Identifier: | NCT01330602 History of Changes |
| Other Study ID Numbers: | DSRB-C/10/005 |
| Study First Received: | May 11, 2010 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Additional relevant MeSH terms:
|
Arteriosclerosis Atherosclerosis Cardiovascular Diseases Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013