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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Cardiovascular Diseases
Intervention Behavioral: Intervention
Enrollment 3532
Recruitment Details

Information and collection informed consent: April 11 2012- June 1 2016 at the occasion of participation in the Västerbotten Intervention Program, Sweden, an ongoing CVD prevention program targeting residents at ages 40, 50 and 60 years

Inclusion in the trial: April 29 2013-June 7 2016 at the Clinical research center, Umea University Hospital

Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

Intervention: Information about carotid ultrasound results to the participant and his/her primary care physician. Carotid intima-media thickness was presented as vascular age illustrating the individual’s biological compared to chronological age, with a gauge going from green (at least 10 years younger), to yellow, orange or red (at least 10 years older). Plaque formation was a traffic light (green - no plaque, red - plaque). 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.

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 CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
Period Title: Overall Study
Started 1749 1783
Completed 1599 1576
Not Completed 150 207
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. 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.

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 CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period. Total of all reporting groups
Overall Number of Baseline Participants 1749 1783 3532
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1749 participants 1783 participants 3532 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1749
 100.0%
1783
 100.0%
3532
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1749 participants 1783 participants 3532 participants
Female
940
  53.7%
930
  52.2%
1870
  52.9%
Male
809
  46.3%
853
  47.8%
1662
  47.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 1749 participants 1783 participants 3532 participants
1749 1783 3532
[1]
Measure Description: Region Västerbotten, Sweden
Framingham Risk Score   [1] 
Mean (Standard Deviation)
Unit of measure:  % risk of CVD within 10 years
Number Analyzed 1749 participants 1783 participants 3532 participants
12.9  (9.6) 12.8  (9.1) 12.9  (9.3)
[1]
Measure Description:

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 blood pressure, treatment for high blood pressure, diabetes, smoking and age.

This 10-year risk is evaluated as a continuous variable or categorized into five categories: Low risk (<5%), Light risk (5-9%), Moderate risk (10-19%), High risk (20-39%), Very high risk (>=40%)

1.Primary Outcome
Title Framingham Score Evaluation
Hide Description 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
Time Frame one year, three years, 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. 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.

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 CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
Overall Number of Participants Analyzed 1599 1576
Mean (Standard Deviation)
Unit of Measure: % risk of CVD within 10 years
12.3  (9.5) 13.3  (9.8)
2.Secondary Outcome
Title SCORE Evaluation
Hide Description

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%)

Time Frame one, three and six years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Life Style
Hide Description Patient questionnaire. Composite measure.
Time Frame one, three and six years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Hospitalizations Due to Stroke and Myocardial Infarctions
Hide Description 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.
Time Frame 10 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Hospitalizations Due to Revascularizations
Hide Description Data will be collected from the Causes of Deaths registry at the National Board of Health and Welfare.
Time Frame 10 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cause-specific Mortality Due to Myocardial Infarctions and Stroke
Hide Description Data will be collected the Causes of Deaths registry at the National Board of Health and Welfare.
Time Frame 10 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Total Mortality
Hide Description 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.
Time Frame 10 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Carotid Ultrasonography Results
Hide Description Compound measure
Time Frame 3 and 6 years
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Pharmacological Treatment, Composite Outcome
Hide Description

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

Time Frame 1, 3 and 6 years
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Intervention: Pictorial information about carotid ultrasound results to the participant and his/her primary care physician. Asymptomatic atherosclerosis presented as vascular age with a gauge going from green (biological age 10 years younger than chronological age), over yellow, orange to red (10 years older). Plaque formation shown as a traffic light with a green dot (no plaque) or red dot (plaque) for each side. 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.

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 CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   5/1749 (0.29%)      2/1783 (0.11%)    
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1749 (0.00%)      0/1783 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/1749 (2.86%)      0/1783 (0.00%)    
Psychiatric disorders     
Anxiety * [1]  50/1749 (2.86%)  50 0/1783 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Anxiety due to information about subclinical atherosclerosis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Margareta Norberg
Organization: Umea University, Sweden
Phone: +46907865544
EMail: margareta.norberg@umu.se
Publications of Results:
Layout table for additonal information
Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT01849575    
Other Study ID Numbers: VIPVIZA version 20121204
First Submitted: May 3, 2013
First Posted: May 8, 2013
Results First Submitted: April 8, 2020
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020