Summary information

Study title

VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program

Creator

Norberg, Margareta (Department of Epidemiology and Global Health, Umeå University)
Näslund, Ulf (Public Health and Clinical Medicine, Umeå University)
Wennberg, Patrik (Family Medicine, Umeå University)
Department of Public Health and Clinical Medicine, Umeå University

Study number / PID

2020-204-1-1 (SND)

Data access

Restricted

Series

Not available

Abstract

The aim of the project is to develop better methods for prevention of cardiovascular diseases (CVD). It is based on the hypothesis that image-based information on subclinical atherosclerosis (i) increases the precision in the assessment of risk of CVD, (ii) improves communication and understanding of the risk, and as a consequence (iii) the motivation for and adherence to evidence-based pharmacological treatment and lifestyle modification will increase. In addition to conventional risk factor assessment and CVD prevention within the framework of Västerbotten Intervention Program. 3500 healthy participants with low/moderate risk of CVD underwent ultrasound examination of the carotid arteries and were randomized to two groups. In the intervention group, the participants and their doctors received pictorial and graphic information in color about the participant’s subclinical atherosclerosis. No information about the ultrasound results was given to the control group. Follow-up after 1, 3 and 6.5 years includes sampling regarding clinical risk factors, blood for biomarker analyses, extensive questionnaires and interviews. At 3 and 6.5 years the ultrasound examination was repeated and all participants and their doctors were informed about the results. The database also includes register data regarding prescriptions of preventive medication, exposure data for air pollutants, data from health examinations within the VIP 10 and 20 years before VIPVIZA, and for men conscription data. After 10 years, registry data on endpoints, CVD morbidity and mortality will be collected. Access to VIPVIZA's data portal and research data from VIPVIZA is possible in collaboration with researchers within the VIPVIZA project. For further information, contact PI Ulf Näslund ulf.naslund@umu.se

Methodology

Data collection period

1992 - 1998

Country

Sweden

Time dimension

Not available

Analysis unit

Individual/Patient

Universe

Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease

Sampling procedure

Subjects having at least one cardiovascular risk factor at the occasion of participation in the Västerbotten INtervention Programme: 1) age 40 years and a first-degree relative with a history oc cardiovascular disease at an age younger than 60 years, abdominal obesity, hypertension, diabetes, LDL-cholesterol >= 4.5 mmol/l, smoking. 3) Age 60 years. Exclusion criterion: More than 50% narrowing of the lumen of carotid areteries
Other

Kind of data

Not available

Data collection mode

VIP historical data 20 years before basline
Registry extract and/or access to biobank sample
VIP Historical data 10 years before baseline
Registry extract and/or access to biobank sample
The Swedish Prescribed Drug Register
Registry extract and/or access to biobank sample
VIP baseline (lifestyle)
Registry extract and/or access to biobank sample
Ultrasound baseline
Physical measurements and tests
Psychological (Problem management) , baseline
Self-administered questionnaire
Lifestyle 1 year
Self-administered questionnaire
Lifestyle 1 year
Biological tests
Clinical CVD risk factors and lifestyle habits 3 year
Self-administered questionnaire
Clinical CVD risk factors and lifestyle habits 3 year
Measurements and tests
Ultrasound 3 year
Physical measurements and tests
Psykologiska faktorer och reaktioner på VIPVIZA interventionen (Problemhantering), efter 3 år
Self-administered questionnaire
Included study participants
Military service mustering register
Registry extract and/or access to biobank sample
Included study participants
Biological tests

Funding information

Funder

Swedish Society of Medicine

Grant number

405351, 503111

Funder

Visare Norr (the four Northern Regions)

Grant number

465621, 561591, 741711, 931135

Funder

The Swedish Research Council

Grant number

Dnr 521-2013-2708, 2016-01891, 2017-02246

Funder

Region Västerbotten

Grant number

ALFVLL-298001, ALFVLL-643391

Funder

The Heart and Lung Foundation

Grant number

Dnr 20150369, 20170481)

Access

Publisher

Swedish National Data Service

Publication year

2021

Terms of data access

Access to data through an external actor. Access to data is restricted.

Related publications

Not available