Atherosclerotic Cardiovascular DiseaseIMPRESSNCT01330602
Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis
A study testing IMPRESS intervention in people with Atherosclerotic Cardiovascular Disease and Cardiovascular Disease, run by National University Hospital, Singapore at 3 sites in Singapore.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Cardiovascular Disease
- What is being tested?
- IMPRESS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,310 participants
- Where
- 3 sitesSingapore
- Study dates
- May 2010to Dec 2013
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore, 119228
Ling L Hsi, Assoc Prof, 67725283, mdcllh@nus.edu.sg
- Recruiting
Novena heart Centre
Singapore, 307506
Raymond Lee, Dr, 6397-2004, appt@novenaheartcentre.com.sg
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Poh Shuan Daniel Yeo, MBBS,MRCP(UK),FRCP(Edin),FACC, +6563577831
Poh Shuan Daniel Yeo, MBBS,MRCP(UK),FRCP(Edin),FACC
About this study
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
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
Read the detailed description
Individuals at intermediate risk account for a large proportion of patients presenting with atherosclerotic events. The barriers to reducing this problem relate to the expense of an unselective primary prevention strategy among a group where the majority will not have events, as well as the difficulty of getting apparently well subjects to adhere to lifestyle and pharmacologic management.
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:
- 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
- Being tested
- IMPRESS intervention
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPRESS interventionBehavioural
Also called Lifestyle medication, CIMT measurement, Statin Therapy, Lifestyle Modification
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
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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. Receives: Behavioral: IMPRESS intervention |
| Usual care arm | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CIMT from baseline to three 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
Measured: 3 years
Secondary outcomes (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
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Desley G HEGNEY, Professor, Principal investigator, National University Health system, NUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330602
- Sponsor's protocol ID
- DSRB-C/10/005
- Acronym
- IMPRESS
- Status last verified
- Oct 2013
- First submitted
- 11 May 2010
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01330602
- Acronym / sponsor ID
- IMPRESS / DSRB-C/10/005
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,310 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- May 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Apr 2011 (estimated)
- 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.
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
Detailed description
Individuals at intermediate risk account for a large proportion of patients presenting with atherosclerotic events. The barriers to reducing this problem relate to the expense of an unselective primary prevention strategy among a group where the majority will not have events, as well as the difficulty of getting apparently well subjects to adhere to lifestyle and pharmacologic management.
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:
- 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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: IMPRESS interventionAll 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. |
| Usual care arm | No intervention | –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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| IMPRESS interventionAlso: Lifestyle medication, CIMT measurement, Statin Therapy, Lifestyle ModificationThe 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 | Behavioural | Lifestyle counseling |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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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.
Desley G HEGNEY, Professor principal investigator
National University Health system, NUS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPRESS intervention in people with Atherosclerotic Cardiovascular Disease and Cardiovascular Disease, run by National University Hospital, Singapore at 3 sites in Singapore.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khong Y Tang, Ms (65167456, nurkyt@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CIMT from baseline to three years (time frame: 3 years). 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 10 Oct 2013.