Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000222044
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
17/03/2010
Date last updated
24/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intima-Media thickness guidance of Primary prevention in Relatives of individuals with Early onSet atherosclerosiS
Scientific title
Comparison of an individualised atherosclerosis-specific prevention program with usual care in those with close relatives who have suffered from premature cardiovascular disease
Secondary ID [1] 1503 0
None
Universal Trial Number (UTN)
Trial acronym
IMPRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic burden 256809 0
Condition category
Condition code
Cardiovascular 256959 256959 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lifestyle intervention including the use of cardiovascular absolute risk and Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK) Scores, total cholesterol levels and carotid intima-media thickness measurements to direct an individual participant's health and lifestyle requirements for the reduction of atherosclerotic burden and cardiovascular risk profile. Overall, participants will be followed-up over a 36 month period and the intervention involves acting on the results of assessment of the following: physical examination, pathology testing, lifestyle and diet questions, an absolute cardiovascular risk profile, quality of life, mental health and functional capacity, the electrical signalling of the heart (electrocardiogram) and carotid intima-media thickness measurement. A self-care plan will be developed for those of higher need who will also have phone or email contact from a cardiac nurse at 1 month post-randomisation and a clinic visit at 3 months post-randomisation.

Additionally, those with a total cholesterol of >5.5mmoL/L or a carotid intima-media thickness greater than one standard deviation for their age will be prescribed 40mg per day of an oral statin for the duration of the study to further reduce their risk of experiencing a cardiovascular event.
Intervention code [1] 256014 0
Prevention
Intervention code [2] 256097 0
Early detection / Screening
Comparator / control treatment
Usual care involving the usual care that the participant's physician provides for any required medical management or direction towards health prevention strategies. We will put no restrictions and make no suggestions as to these participant's management. As with any individual, medical management in this group will involve assessment on a case-by-case basis according to what is required.
Control group
Active

Outcomes
Primary outcome [1] 257941 0
Change in common carotid intima-media thickness measurements
Timepoint [1] 257941 0
At baseline and at 18 months and three years post-randomisation
Secondary outcome [1] 263454 0
Change in plaque length in the carotid artery. Plaque length will be measured at the same time as carotid intima-media thickness via carotid ultrasound.
Timepoint [1] 263454 0
At baseline and at 18 months and three years post-randomisation
Secondary outcome [2] 263455 0
Change in internal carotid artery intima-media thickness measurement
Timepoint [2] 263455 0
At baseline and at 18 months and three years post-randomisation
Secondary outcome [3] 263456 0
Change in quality of life and general well-being (via the Short Form-12 [SF-12] and EuroQol 5-dimensions [EQ-5D] questionnaires).
Timepoint [3] 263456 0
At baseline and at 18 months and three years post-randomisation
Secondary outcome [4] 263457 0
Change in mental health (as determined by the Arrol questionnaire and the Centre for Epidemiological Studies Depression Scale [CESD] if the Arrol questionnaire is positive for identification of possible depression).
Timepoint [4] 263457 0
At baseline and at 18 months and three years post-randomisation
Secondary outcome [5] 263458 0
Difference in health care costs between usual care and intervention cohorts. This will be assessed through access of Medicare data for each participant throughout the life of the study. Costs of those in the intervention group will be compared with those in the usual care group.
Timepoint [5] 263458 0
From baseline to three years post-randomisation
Secondary outcome [6] 263459 0
Change in modifiable risk factors for atherosclerotic disease other than diabetes (i.e. smoking, dyslipidaemia, obesity and hypertension). This will be done by querying a participant's lifestyle and medical tests (for dyslipidaemia and hypertension) and follow-up of these results throughout the study (following education as to how to reduce these risk factors).
Timepoint [6] 263459 0
At baseline and at six months, 18 months and three years post-randomisation
Secondary outcome [7] 263460 0
Change in absolute cardiovascular risk profile and risk of diabetes (determined by the AUSDRISK Score)
Timepoint [7] 263460 0
At baseline and at three months, six months, 18 months and three years post-randomisation
Secondary outcome [8] 263461 0
All-cause mortality which will be assessed by accessing data from the National Death Index at the conclusion of the trial.
Timepoint [8] 263461 0
From baseline to three years post-randomisation
Secondary outcome [9] 263462 0
Cardiovascular hospitalisation which will be assessed by accessing a participant's medical records and obtaining Medicare data for each participant.
Timepoint [9] 263462 0
From baseline to three years post-randomisation

Eligibility
Key inclusion criteria
1. Have a first-degree relative (i.e. a mother, father, brother or sister) with premature (onset before 60 years) cardiovascular disease
2. Are classified as being at "intermediate risk" of experiencing a cardiovascular event in the next five years as determined by the Framingham Risk Equation
3. Are living independently in the community or in their own home
4. Are able and willing to provide written informed consent to participate
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have pre-existing atherosclerotic cardiovascular disease

2. Have Diabetes (any type)

3. Have contraindications to the use of statin medications

4. Unable to provide written informed consent to participate in this study

5. Have a terminal malignancy requiring palliative care, or a limited life expectancy or any other medical condition that results in the belief of the Chief Investigators that it is not appropriate for the patient to participate in this trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with carotid intima-media thickness and total cholesterol level used for stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2010
Actual
15/02/2010
Date of last participant enrolment
Anticipated
Actual
9/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
397
Accrual to date
Final
372
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 2068 0
The Alfred - Prahran
Recruitment hospital [2] 2069 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 2070 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 7765 0
3004 - Melbourne
Recruitment postcode(s) [2] 7766 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 7767 0
2605 - Garran
Recruitment outside Australia
Country [1] 2494 0
Singapore
State/province [1] 2494 0
Singapore

Funding & Sponsors
Funding source category [1] 256590 0
Government body
Name [1] 256590 0
National Health and Medical Research Council (NHMRC) Program Grant
Country [1] 256590 0
Australia
Primary sponsor type
University
Name
University of Queensland- School of Medicine
Address
Princess Alexandra Hospital
Ipswich Road
Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 255884 0
Other Collaborative groups
Name [1] 255884 0
Baker IDI Heart & Diabetes Institute
Address [1] 255884 0
75 Commercial Road
Melbourne, VIC 3004
Country [1] 255884 0
Australia
Secondary sponsor category [2] 255885 0
University
Name [2] 255885 0
National University Health System
Address [2] 255885 0
5 Lower Kent Ridge Road
Singapore 119074
Country [2] 255885 0
Singapore
Secondary sponsor category [3] 287406 0
University
Name [3] 287406 0
Australia National University
Address [3] 287406 0
Barry Dr, Acton
ACT 0200
Country [3] 287406 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258620 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 258620 0
Ethics committee country [1] 258620 0
Australia
Date submitted for ethics approval [1] 258620 0
Approval date [1] 258620 0
02/02/2010
Ethics approval number [1] 258620 0
HREC/09/QPAH/202
Ethics committee name [2] 258621 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 258621 0
Ethics committee country [2] 258621 0
Australia
Date submitted for ethics approval [2] 258621 0
Approval date [2] 258621 0
05/03/2010
Ethics approval number [2] 258621 0
Project No: 16/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30839 0
Prof Tom Marwick
Address 30839 0
Menzies Research Institute Tasmania
Private bag 23, Hobart
Tasmania 7000
Country 30839 0
Australia
Phone 30839 0
+613 6226 7703
Fax 30839 0
+613 6226 7704
Email 30839 0
[email protected]
Contact person for public queries
Name 14086 0
Melinda Carrington
Address 14086 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 14086 0
Australia
Phone 14086 0
+61399533688
Fax 14086 0
+61396635726
Email 14086 0
[email protected]
Contact person for scientific queries
Name 5014 0
Melinda carrington
Address 5014 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 5014 0
Australia
Phone 5014 0
+61399533688
Fax 5014 0
+61396635726
Email 5014 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.