None listed
Conditions
Brief summary
This study will use carotid intima-media thickness, a marker of atherosclerosis, 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 disease management program strategy to optimise their successful application in the longer-term. Therefore, the study hypothesis is that in intermediate risk, first-degree relatives (mother, father, brother or sister) of individuals with premature atherosclerosis, a carotid intima-media thickness-targeted disease management program for primary prevention incorporating more intensive non-pharmacological and pharmacological management, provides better reduction of atherosclerotic burden than usual health care management during 36 months follow-up.
Interventions
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
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.
Sponsors
University of Queensland- School of Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed