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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National University Hospital, Singapore
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01330602
First received: May 11, 2010
Last updated: October 8, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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:

  • 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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330602

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

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01330602     History of Changes
Other Study ID Numbers: DSRB-C/10/005
Study First Received: May 11, 2010
Last Updated: October 8, 2013
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 November 25, 2014