Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis (IMPRESS)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Atherosclerotic Cardiovascular Disease; Cardiovascular Disease	Behavioral: IMPRESS intervention	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1310 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	May 2010
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
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: 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.	Behavioral: 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 Names: Lifestyle medication; CIMT measurement; Statin Therapy; Lifestyle Modification
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

Outcome Measures

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Primary Outcome Measures :

1. Change in CIMT from baseline to three years [ Time Frame: 3 years ]

   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

Secondary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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Contacts

Contact: Khong Y Tang, Ms	65167456	nurkyt@nus.edu.sg
Contact: Kee B Leng, Mdm	65167456	nurkblb@nus.edu.sg

Locations

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
Tan Tock Seng Hospital	Recruiting
Singapore, Singapore, 308433
Contact: Poh Shuan Daniel Yeo, MBBS,MRCP(UK),FRCP(Edin),FACC +6563577831
Principal Investigator: Poh Shuan Daniel Yeo, MBBS,MRCP(UK),FRCP(Edin),FACC

Sponsors and Collaborators

National University Hospital, Singapore

National University, Singapore

Investigators

Principal Investigator:	Desley G HEGNEY, Professor	National University Health system, NUS

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT01330602 History of Changes
Other Study ID Numbers:	DSRB-C/10/005
First Posted:	April 7, 2011
Last Update Posted:	October 10, 2013
Last Verified:	October 2013

Additional relevant MeSH terms:

Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases