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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3532 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
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.
|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.|
|Actual Study Start Date :||April 7, 2013|
|Actual Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2027|
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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|