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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

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3532 participants
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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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
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

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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%)


  2. Life Style [ Time Frame: one, three and six years ]
    Patient questionnaire. Composite measure.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Carotid Ultrasonography Results [ Time Frame: 3 and 6 years ]
    Compound measure


Other Outcome Measures:
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sweden
Clinical Reseach Center Umeå University Hospital
Umeå, Sweden, Se-90185
Sponsors and Collaborators
Umeå University
Västerbotten County Council, Sweden
Investigators
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Principal Investigator: Margareta Norberg, MD, PhD Umeå University
Principal Investigator: Ulf Näslund, Professor,MD Umeå University Hospital
  Study Documents (Full-Text)

Documents provided by Umeå University:
Informed Consent Form  [PDF] May 29, 2018
Study Protocol  [PDF] November 26, 2019

Publications of Results:

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT01849575    
Other Study ID Numbers: VIPVIZA version 20121204
First Posted: May 8, 2013    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umeå University:
Ultrasonography
Cardiovascular diseases
Prevention
Risk communication
Risk assessment
Behavioral change
Additional relevant MeSH terms:
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Cardiovascular Diseases