Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention (VIPVIZA)
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|ClinicalTrials.gov Identifier: NCT01849575|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Last Update Posted : September 25, 2017
|First Submitted Date ICMJE||May 3, 2013|
|First Posted Date ICMJE||May 8, 2013|
|Last Update Posted Date||September 25, 2017|
|Actual Start Date ICMJE||April 2013|
|Estimated Primary Completion Date||June 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Framingham score evaluation [ Time Frame: 12 and 36 months ]
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
|Original Primary Outcome Measures ICMJE
||Conventional cardiovascular risk factors [ Time Frame: 12 month ]
S-LDL-cholesterol, S-triglycerides, S-cholesterol, Systolic and diastolic Blood pressure, HbA1c, fasting glucose, BMI, waist, SCORE evaluation
|Change History||Complete list of historical versions of study NCT01849575 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
||Life style [ Time Frame: 12 month and three years ]
|Current Other Outcome Measures ICMJE
||Pharmacological treatment, composite outcome [ Time Frame: 1, 3 and 5 years after baseline ]
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
|Original Other Outcome Measures ICMJE
|Brief Title ICMJE||Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention|
|Official Title ICMJE||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.|
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.
Visualization of asymptomatic atherosclerotic disease to improve cardiovascular prevention. Design of a randomized controlled intervention within ordinary health care - VIPVIZA.
Design and methods: a randomized controlled trial integrated in the existing set-up for population based CVD screening and prevention within primary health care, the Västerbotten Intervention Programme (VIP). VIP provides CVD risk factor screening and individual health promotion to all county citizens at ages 40, 50 and 60 years with high participation rate (around 70%), only small social selection bias and standardized procedures.
Study population: VIP-participants were invited to the study according to inclusion criteria. This design guarantees a population base for the study, focus on individuals at intermediate CVD-risk, clinical relevance and external validity.
Sample size and power: Power calculations were based on VIP data on CVD risk factors 2011, and on CIMT data from the Tromsö study, Norway. Enrolment of 3200 participants was estimated sufficient to test outcomes with a probability of 0.8 to detect a true difference between groups at a significance level of 0.05. To compensate for drop-outs during the study period, of 3600 individuals were recruited.
Population sample Inclusion criteria: i) age 60 years, ii) a history of CVD before age 60 years among first-degree relatives iii) age 50 years and at least one of the following: smoking, diabetes, hypertension, S-LDL-cholesterol ≥ 4.5 mmol/L, abdominal obesity.
Exclusion criteria: a significant stenosis as defined by >50% luminal narrowing of the investigated carotid arteries according to vascular ultrasound and Doppler measurements.
Participants are randomly with equal probability assigned to two groups. Intervention Image-based risk communication, i.e. visual 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. After 2─4 weeks a follow─up call by a research nurse, to give additional information and reassurance, if needed.
Control No information about the carotid ultrasound to participant and physician.
Both groups are followed and managed according to clinical guidelines within primary health care during the entire study period.
Outcome definitions for differences between intervention and control group:
Primary outcome: CVD risk as evaluated by statistical risk model based on conventional risk factors at one year. Variable: Framingham risk score at one-year follow-up (Specific aim 1). This is a surrogate variable for change of atherosclerosis as assessed by carotid intima media thickness and presence of plaque. The atherosclerotic process is too slow and the precision in ultrasound measurements too low to allow for evaluations between intervention and control group after one year.
Secondary outcomes: The secondary outcomes are divided into three categories, corresponding specific aims are indicated.
Psychological and behavioral factors, determinants and mediators of preventive actions:
Data analyses, statistical analytical tests: Parametric and non-parametric tests will be used as appropriate. Imaging results will be related to the risk factors establishing multiple linear regression models. Predictive Cox Proportional Hazard models will be developed to estimate the overall predictive ability of CIMT, plaque and risk factors on CVD morbidity and mortality at 5 and 10 years taking into account time at risk for disease and deaths. Receiver Operating Characteristic Curves (ROC) by estimating the Area Under the Curve (AUC) to assure highest possible sensitivity and specificity of predictions. Confirmatory (structural equation modelling) and exploratory (partial least squares analysis) statistical modelling employed to establish relationships between the intervention and intermediate and mediating factors and variables' relative contribution to explain changes in the outcome variables.
Qualitative analyses, Deep interviews with participants and physicians will be transcribed verbatim and analyzed using Qualitative Content Analysis.
Time plan: Recruitment and base line measurements were completed June 2016 (In VIP: CVD risk factors, life style questionnaire and sampling of frozen blood to the Medical Biobank. Carotid ultrasound and psychometric questionnaires, interviews).
1-year follow-up started May 2014, will be completed June 2017. (CVD risk factors, life style questionnaire) 3-year follow-up starts August 2016, will be completed June 2019 (CVD risk factors, life style questionnaire, frozen blood samples, carotid ultrasound and psychometric questionnaires, pharmacologic treatments.
5 and 10-year follow-up for clinical events, register data 2021 and 2026. Period for this application: 2017-2019, the second phase of data collection from participants.
Implementation: The project is conducted as an integrated part of clinical care. Evaluations and prevention based on ultrasound results and risk factors are done by family physicians according to clinical guidelines in routine care. The carotid ultrasound examinations are performed with a portable machine that can easily be used in settings outside specialized care. The procedure takes only 10-15 minutes, the methodology is user friendly and automated, follows a strict protocol, and can after a short learning period be performed by non-specialized staff. The existing software provides a report that can accurately be interpreted by patients and doctors. Therefore, the results and methods are expected to be relevant, valid and ready for direct implementation in other CVD prevention programs, including being decentralized and performed on an everyday basis in high volumes by non-specialized staff. If necessary, evaluations by a specialist can be done at long distances within specialized care as ultrasound results can be electronically transferred.
Organisation: The source population is the whole middle-aged county population, from the more densely-populated urbanized coastland to the sparsely-populated rural inland. The research environment is interdisciplinary with a strong multi-professional team of researchers with solid experience of clinical prevention and research in the field. For the practical project work a close collaboration is important between the applicant and the medical coordinator of VIP with representatives of Heart Centre including Clinical Physiology, Stroke center, Behavioral Medicine. Additional specialists in the team are; cardiology, image based techniques, internal medicine, family medicine, behavioral medicine, epidemiology and global health, psychology, statistics, qualitative methods. For biomarker research we collaborate with, Umeå Plant Science Centre (omics), SciLifeLab Uppsala, and Uppsala Clinical Research Center. Research on ultrasound technical development is a collaboration between Heart Centre and Departments of Biomedical Engineering and Radiation Sciences. Agreements about premises, staff, research nurses and technicians are made long-term. The County Council has authorized the study all over the county.
Premises and facilities: The daily work is managed and organized by experienced research nurses at the Clinical Research Centre, Umeå University Hospital, where about 50% of the ultrasound examinations are performed. In the remote districts they are performed at the primary health care centers with use of the same portable ultrasound machine. VIP-nurses working continuously with prevention at each PHC are deeply involved for recruitment and 1- and 3-year follow-up measurements. The Clinical Trial Unit, another research supporting facility hosted by the county council, will monitor the trial according to GCP.
ETHICAL APPROVAL All individuals participating in the study has to provide written informed consent. The Regional Ethical Review Board, Umeå University, has approved the VIPVIZA study including the above described substudies (Dnr 2011-445-31M,2012-463-32M, 2013-373-32M) .
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Condition ICMJE||Cardiovascular Diseases|
|Intervention ICMJE||Behavioral: Intervention
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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||June 2021|
|Estimated Primary Completion Date||June 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
- Participant in the Västerbotten Intervention Programme
|Ages||40 Years to 60 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Sweden|
|Removed Location Countries|
|NCT Number ICMJE||NCT01849575|
|Other Study ID Numbers ICMJE||VIPVIZA version 20121204|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||
|Responsible Party||Umeå University|
|Study Sponsor ICMJE||Umeå University|
|Collaborators ICMJE||Västerbotten County Council, Sweden|
|PRS Account||Umeå University|
|Verification Date||March 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP