Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention (VIPVIZA)
This population based randomized controlled trial (RCT) aims at optimizing cardiovascular disease (CVD) prevention through accurate identification of individuals at high risk of CVD and accurate perception of the risk, and better compliance to preventive treatments and reduced premature CV morbidity and mortality Increased carotid artery intima-media thickness (CIMT) and carotid plaques, assessed by ultrasonography, are early signs of atherosclerosis and associated with myocardial infarction and stroke. Few studies have systematically evaluated image-based risk stratification and its effect on clinical outcomes and results are conflicting.
The Västerbotten Intervention Programme (VIP), Northern Sweden, is integrated in primary care services with assessment of traditional CV risk factors and individual health promoting counseling for all 40-, 50- and 60-year olds (n=6500/yr). Those with diabetes, hypertension, family history of premature CVD and/or hypercholesterolemia are referred to treatment.
VIP participants with at least one conventional CV risk factor (60% of participants) are eligible for inclusion in VIPVIZA. During 2013-2015, 3200 participants will be enrolled. Portable carotid ultrasound machines will be used for ultrasound examinations, whereby CIMT and plaque formation will be visualized and measured.
Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written information to patient and physician, including graphic presentation in color of CIMT and of plaque, vascular age, an ultrasound image, general information about atherosclerosis as a dynamic process, and recommendation to follow clinical guidelines for risk factor control. 2/ Control: No information from the baseline ultrasonography.
We will explore determinants of behavioral change using psychometric questionnaires and level of health literacy. Deep interviews at the time point for the ultrasound examinations will explore how the screening relates to risk perception, quality of life, coping strategies, attitudes to and skills of self-care.
Both groups will be managed according to clinical guidelines within the usual health care. After three years (2015-2017), the ultrasonography is repeated and information given to all participants and their physicians.
CV risk factors, life style and pharmacological treatments will be assessed after one and three years. CV morbidity and mortality and all-cause mortality will be followed during five years, i.e. until 2020.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Direct VIsualiZAtion of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention. A Population Based Pragmatic Randomised Controlled Trial Within Västerbotten Intervention Programme (VIP) and Ordinary Care.|
- Framingham score evaluation [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]Composite gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual, based on levels of blood pressure, total cholesterol, LDL-cholesterol, systolic bloodpressure, treatment for high blood pressure, diabetes, smoking and age
- SCORE evaluation [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]Risk of death in myocardial infarction within 10 years expressed as statistical assessment based on smoking, systolic blood-pressure, blood cholesterol, age and sex.
- Life style [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]Patient questionnaire. Composite measure.
- Hospitalizations due to stroke and myocardial infarctions [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]Data will be collected from computerized medical records from hospital care in the county and from the In-patient registry at the National Board of Health and Welfare.
- Hospitalizations due to revascularizations [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]Data will be collected from the Causes of Deaths registry at the National Board of Health and Welfare.
- Cause-specific mortality due to myocardial infarctions and stroke [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]Data will be collected the Causes of Deaths registry at the National Board of Health and Welfare.
- Total mortality [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]Data will be collected from computerized medical records from hospital care in the county, regional quality registry on myocardial infarctions and from the In-patient registry at the National Board of Health and Welfare.
- Carotid ultrasonography results [ Time Frame: 3 years ] [ Designated as safety issue: No ]Compound measure
- Pharmacological treatment, composite outcome [ Time Frame: 1, 3 and 5 years after baseline ] [ Designated as safety issue: No ]
Prescriptions of medications for hypertension, diabetes and dyslipidemia. Data collected from computerized medical records in primary and hospital care in the county.
Purchases of medications for hypertension, diabetes and dyslipidemia followed through data from the Pharmaceutical registry, National Board of Health and Wellfare
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||June 2021 (Final data collection date for primary outcome measure)|
Active Comparator: Intervention
The intervention: Giving communication about risk of cardiovascular disease in the form of written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness, highlighted as vascular age, and plaque formation, visualized as a traffic light (green - no plaque, red - plaque).The ultrasound results are given to the study person and his/her physician, in addition to information about conventional risk factors for cardiovascular disease
Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2─4 weeks a follow─up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.
CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
Other Name: Information about ultrasound results
No Intervention: Control
The comaparator is that the study person and his/her physician do not get any information about carotid ultrasound results on silent atherosclerosis. They are only informed about results of measured conventional CVD risk factors
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01849575
|Clinical Reseach Center Umeå University Hospital|
|Umeå, Sweden, Se-90185|
|Principal Investigator:||Margareta Norberg, MD, PhD||Umeå University|
|Principal Investigator:||Ulf Näslund, Professor,MD||Umeå University Hospital|