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Visualization of Asymptomatic Atherosclerotic Disease for Optimum Cardiovascular Prevention (VIPVIZA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849575
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Umeå University

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE April 8, 2020
Results First Posted Date  ICMJE May 7, 2020
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE April 7, 2013
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
Framingham Score Evaluation [ Time Frame: one year, three years, 6 years ]
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
 (submitted: May 7, 2013)
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
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • SCORE Evaluation [ Time Frame: one, three and six years ]
    Risk of death (%) in myocardial infarction within 10 years expressed as statistical assessment based on smoking, systolic blood-pressure, blood cholesterol, age and sex. SCORE is evaluated as a continuous variable ir categorized in four categories: Low risk (<1%), Moderate risk (1-4%), High risk (5-9%), Very high risk (>=10%)
  • Life Style [ Time Frame: one, three and six years ]
    Patient questionnaire. Composite measure.
  • Hospitalizations Due to Stroke and Myocardial Infarctions [ Time Frame: 10 years ]
    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: 10 years ]
    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: 10 years ]
    Data will be collected the Causes of Deaths registry at the National Board of Health and Welfare.
  • Total Mortality [ Time Frame: 10 years ]
    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 and 6 years ]
    Compound measure
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Life Style [ Time Frame: 12 month and three years ]
Patient questionnaire
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2020)
Pharmacological Treatment, Composite Outcome [ Time Frame: 1, 3 and 6 years ]
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 Pre-specified Outcome Measures
 (submitted: May 7, 2013)
  • Ultrasound results [ Time Frame: Three years from baseline ]
    Carotid Intima Media Thickness Carotid plaques: Total plaque area, Grey scale median (GSM)
  • Pharmacological treatment [ 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 dyslipidemi followed through data from the Pharmaceutical registry, National Board of Health and Wellfare
  • Hard endpoints [ Time Frame: Within five years ]
    Hospitalizations due to myocardial infarctions (MI), stroke, PCI and other revascularizating surgical procedures, and deaths (all-cause and CVD specific). Data will be collected from computerized medical records from primary and hospital care in the county, regional quality registers on MI and stroke and from the In-patient and Causes of Deaths registers, at the National Board of Health and Welfare.
 
Descriptive Information
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.
Brief Summary The purpose of VIPVIZA is to assess the impact of pictorial information about asymptomatic atherosclerotic disease to both physician and patient, for improving physicians' adherence to prevention guidelines and patient perception and understanding of the cardiovascular disease (CVD) risk and consequent motivation for prevention. The intervention effect is assessed by differences between randomization groups in the primaryboutcome Framingham Risk Score (FRS) and the secondary outcomes the Systematic COronary Risk Evaluation (SCORE) as well as changes in these scores after one, three and six years. Secondary outcomes are also atherosclerotic disease progression, as assessed by repeated carotid ultrasound examination after three and six years, as well as the prevalence of acute events and mortality after 10 years . Social, psychological and cognitive determinants of behavioral change as well as the intervention impact on novel biomarkers will also be explored.
Detailed Description

Project description

The main objective of this project is to contribute to improved primary prevention of cardiovascular disease through the provision of a visual image and pictorial report of atherosclerosis while still asymptomatic. The image and report are seen and discussed by both physician and patient in order to improve guideline adherence and patient perception and understanding of the CVD risk and consequent motivation for prevention. The specific objectives include: 1. To assess the prevalence of asymptomatic atherosclerotic disease in men and women through identification of carotid plaques and measurement of carotid intima-media thickness (CIMT), and to relate plaques and CIMT to clinically estimated CVD risk factors and risk scores; 2. To explore the impact of pictorial representations of atherosclerosis on physicians´ adherence to prevention guidelines, and on individuals' quality of life, preventive measures, risk factor control and progress of atherosclerotic disease over the course of three and six years, as well as on premature CVD morbidity and mortality over the course of 5 and 10 years; 3. To evaluate how individuals' social, psychological, and cognitive characteristics relate to health behaviours, atherosclerosis and CVD risk at baseline and progression of any atherosclerosis; 4. To investigate biomarkers in relation to CIMT and plaques at baseline, changes in conventional CVD risk markers and lifestyle, and progression of atherosclerosis.

Survey of the field Primary prevention of CVD often fails due to poor adherence among practitioners and patients to evidence-based prevention guidelines on effective modification of risk factors by lifestyle change and pharmacological treatment. Contributory factors include poor communication about the CVD risk by the physician and inaccurate risk perception among patients. The risk message is usually communicated verbally or numerically, while potentially more effective visual tools are seldom used. For the clinical assessment of CVD risk the FRS and the European SCORE are most widely used. However, evidence that their use translates into reduced CVD morbidity and mortality is scarce. These risk scores focus on high-risk individuals, despite 60-70% of all CVD events occurring among individuals at low or intermediate risk for CVD. They might also be too abstract to lead to accurate risk perception and to motivate individuals to take preventive actions; information alone seldom results in rational behavior modification. VIPVIZA takes a different approach from current practice for the prevention of CVD. Instead of being based solely on indirect risk factors, this project evaluates the atherosclerotic disease itself while it still is subclinical, providing improved assessment, communication and perception of the CVD risk and hence greater motivation for prevention. This is achieved with ultrasonography of medium sized arteries with assessment of CIMT and existing atherosclerotic plaques.

Design, setting and study population:

The study is a pragmatic randomised open-label controlled trial with blinded evaluators (PROBE). VIPVIZA is integrated in and added to the ordinary Västerbotten Intervention Programme (VIP). Individuals with at least one clinical CVD risk factor were invited to the VIPVIZA trial when they participated in VIP (n=4177), resulting in inclusion of 3532 participants. Baseline visits with ultrasound examinations were carried out from April 29 2013 to June 7 2016. Participants were consecutively and randomly allocated to two groups (intervention and control group) using a computer-generated randomization list. The ultrasound examinations in VIPVIZA at baseline as well as after three and six years are performed at the hospitals in the three cities/towns (Umeå, Skellefteå, Lycksele), and in remote rural areas at primary health care centres. Risk factor measurements and questionnaires at follow-up after one, three and six years are carried out for participants living in Umeå at the Clinical Research Centre at Umeå University Hospital, and for participants in the rest of the county at their local primary health care center. Both groups are managed according to clinical guidelines for CVD prevention within primary care (not by the study team).

Intervention At baseline, pictorial representation of the carotid ultrasound results was given to each participant in the intervention group and their primary care physician. Atherosclerosis was presented as vascular age, with a gauge ranging from green through yellow, orange and red to illustrate the individual's biological age compared to chronological,age. A red or a green circle, like a traffic light, illustrated detected or no detected plaque, respectively. Brief written information about atherosclerosis as a dynamic process that is modifiable by a healthy lifestyle and pharmacological treatment, an interpretation of the result and general advice on CVD prevention were included. After 2-4 weeks, participants received a follow-up phone call by a research nurse in order to reassure and give additional information as needed. The same pictorial information was repeated to participants after 6 months. No information about the ultrasound result was given to the control group and their physicians.

At three- and six-year follow-up both the intervention and the control group participants and their respective primary care physician receive information about ultrasound results with the same format as was given to the intervention group at baseline. Thus, the intervention is completed at the time-point for three-year follow-up. After that the two groups are continuously followed through registries and compared with respect to atherosclerosis development and hard outcomes.

Data collection:

Clinical risk factors for cardiovascular disease: Measured at the baseline VIP health survey, at 1-, 3- and 6-year follow-up (blood pressure, lipids, and glucose, BMI and waist circumference).

Questionnaires: The VIP questionnaire covers health, socioeconomic situation, quality of life (RAND 36), lifestyle (physical activity, tobacco and alcohol consumption, diet), working conditions, social network. Validated psychometric instruments at baseline and 3-year follow-up included health literacy, coping strategies, an optimism-pessimism scale, self-efficacy, HADS and self-rated risk of CVD. Perceptions about preventive medication and a stress questionnaire at the 3-year follow-up. At 3-year follow-up questions on health literacy, coping strategies and optimism/pessimism are replaced by questionnaires on personality and dental care.

Carotid ultrasound examinations are performed at baseline, after 3 and6 years according to a standardized protocol.

Interviews: With subsamples of participants after the first, second and third ultrasound examination, and with primary care physicians after the first ultrasound examination.

Stored samples of blood to the Medical Biobank: This is done at the baseline VIP visit and at 3- and 6-year follow-up among participants, to be used for analyses of novel biomarkers Register data: Prescriptions, visits and risk factor measurements from the medical records system in Västerbotten County. Dental health and dental radiological examinations from Dental care. The Prescriptions register, Hospitalizations register and Causes of deaths register at the National Board of Health and Welfare. In addition, physical and psychological functioning and blood-group at military patterning at age around 18 from the Conscripts registry (for male participants only), educational level and income from Statistics Sweden and air pollutants by geographical region in the County of Västerbotten.

Time plan The study progress is largely according to the plan. Baseline examinations were conducted April 2013-June 2016, the 1-year follow-up examinations June 2014-August 2017, and the 3-year examinations September 2016 - June 2019. The six-year follow-up examinations started December 2019 which is a delay of 6 months due to administrative reasons. Register data from medical records, Statistics Sweden, the Conscripts register, Air-borne pollutants are underway April 2020. Data on morbidity and mortality will be retrieved in 2027, i.e. one year later than 10 years after trial start due to delay until data on events has been entered into the registries.

Ethical approval:

Study protocol version 4.0:

The VIPIVZA trial: Dnr 2011-445-32M date Feb 7 2012. Amendment 1: Dnr 2012-463-32M date December 19 2012. Amendment 2: Dnr 2013 373-32M date October 15 1013. Amendment 3: Dnr 2016-245-32M date May 31 2016. Amendment 4: Dnr 2017-95-32M date February 27 2017. Amendment 5: Dnr 2018-182-32 date May 28 2018.

Study protocol version 5.0:

Amendment 6: Dnr 2018-482-32M Date December 27 2018. Amendment 7: Dnr 2019-04619 Date September 24 2019.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

The cleaned structured data which is generated from the original data and does not contain personal numbers (identity data) and is stored on an encrypted E: drive on a computer that is exclusively used for VIPVIZA by the data manager. Access only by the data manager with password. The password is only known by the data manager. It is also kept in a sealed envelope in the save of the Medical Faculty.

For each sub-project, data on selected variables in the structured data base is exported to a researcher by the data manager after approval from the VIPVIZA steering group. Thus, the participants' identity is masked for the outcome assessors since they have nu access neither to the original or the structured data.

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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Intervention
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 8, 2018)
3532
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2013)
3200
Estimated Study Completion Date  ICMJE December 31, 2027
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Participant in the Västerbotten Intervention Programme

and

  • 40 years old and a history of CVD at age < 60 years among first-degree relative

or

  • 50 years old and at least one of the following six criteria:
  • a history of CVD at age < 60 years among first-degree relative,
  • smoking,
  • diabetes,
  • hypertension,
  • S-LDL-cholesterol ≥4.5 mmol/L,
  • abdominal obesity

or

  • 60 years old

Exclusion Criteria:

  • Stenosis ≥50% of the carotid lumen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849575
Other Study ID Numbers  ICMJE VIPVIZA version 20121204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE Västerbotten County Council, Sweden
Investigators  ICMJE
Principal Investigator: Margareta Norberg, MD, PhD Umeå University
Principal Investigator: Ulf Näslund, Professor,MD Umeå University Hospital
PRS Account Umeå University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP