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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Umeå University
Sponsor:
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Umeå University
ClinicalTrials.gov Identifier:
NCT01849575
First received: May 3, 2013
Last updated: March 30, 2016
Last verified: December 2015
  Purpose

This population based randomized controlled trial (RCT) aims at optimizing cardiovascular disease (CVD) prevention through accurate identification of individuals at high risk of CVD and accurate perception of the risk, and better compliance to preventive treatments and reduced premature CV morbidity and mortality Increased carotid artery intima-media thickness (CIMT) and carotid plaques, assessed by ultrasonography, are early signs of atherosclerosis and associated with myocardial infarction and stroke. Few studies have systematically evaluated image-based risk stratification and its effect on clinical outcomes and results are conflicting.

The Västerbotten Intervention Programme (VIP), Northern Sweden, is integrated in primary care services with assessment of traditional CV risk factors and individual health promoting counseling for all 40-, 50- and 60-year olds (n=6500/yr). Those with diabetes, hypertension, family history of premature CVD and/or hypercholesterolemia are referred to treatment.

VIP participants with at least one conventional CV risk factor (60% of participants) are eligible for inclusion in VIPVIZA. During 2013-2015, 3200 participants will be enrolled. Portable carotid ultrasound machines will be used for ultrasound examinations, whereby CIMT and plaque formation will be visualized and measured.

Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written information to patient and physician, including graphic presentation in color of CIMT and of plaque, vascular age, an ultrasound image, general information about atherosclerosis as a dynamic process, and recommendation to follow clinical guidelines for risk factor control. 2/ Control: No information from the baseline ultrasonography.

We will explore determinants of behavioral change using psychometric questionnaires and level of health literacy. Deep interviews at the time point for the ultrasound examinations will explore how the screening relates to risk perception, quality of life, coping strategies, attitudes to and skills of self-care.

Both groups will be managed according to clinical guidelines within the usual health care. After three years (2015-2017), the ultrasonography is repeated and information given to all participants and their physicians.

CV risk factors, life style and pharmacological treatments will be assessed after one and three years. CV morbidity and mortality and all-cause mortality will be followed during five years, i.e. until 2020.


Condition Intervention
Cardiovascular Diseases
Behavioral: Information about carotid ultrasound results
Other: No information about the carotid ultrasound results

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Framingham score evaluation [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
    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:
  • SCORE evaluation [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
    Risk of death in myocardial infarction within 10 years expressed as statistical assessment based on smoking, systolic blood-pressure, blood cholesterol, age and sex.

  • Life style [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
    Patient questionnaire. Composite measure.

  • Hospitalizations due to stroke and myocardial infarctions [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]
    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: 5 and 10 years ] [ Designated as safety issue: No ]
    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: 5 and 10 years ] [ Designated as safety issue: No ]
    Data will be collected the Causes of Deaths registry at the National Board of Health and Welfare.

  • Total mortality [ Time Frame: 5 and 10 years ] [ Designated as safety issue: No ]
    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 years ] [ Designated as safety issue: No ]
    Compound measure


Other Outcome Measures:
  • Pharmacological treatment, composite outcome [ Time Frame: 1, 3 and 5 years after baseline ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 3200
Study Start Date: April 2013
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound results communicated
The intervention: Risk communication with written and graphical information about silent atheroscslerosis measured by carotid ultrasound examination as carotid intima-media thickness and plaque formation.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: Information about carotid ultrasound results

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.

Placebo Comparator: Ultrasound results not communicated
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
Other: No information about the carotid ultrasound results

Participant and physician do not get any information about the carotid ultrasound results.

CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849575

Locations
Sweden
Clinical Reseach Center Umeå University Hospital Recruiting
Umeå, Sweden, Se-90185
Contact: Margareta Norberg, MD,PhD    +46 90 785 ext 3343    margareta.norberg@umu.se   
Contact: Ulf Näslund, Professor,MD    +46 90 785 ext 3600    ulf.naslund@vll.se   
Principal Investigator: Margareta Norberg, MD, PhD         
Sponsors and Collaborators
Umeå University
Västerbotten County Council, Sweden
Investigators
Principal Investigator: Margareta Norberg, MD, PhD Umeå University
Principal Investigator: Ulf Näslund, Professor,MD Umeå University Hospital
  More Information

Publications:
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126.

Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT01849575     History of Changes
Other Study ID Numbers: VIPVIZA version 20121204 
Study First Received: May 3, 2013
Last Updated: March 30, 2016
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Ultrasonography
Cardiovascular diseases
Prevention
Risk communication
Risk assessment
Behavioral change

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 30, 2016