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

This study is currently recruiting participants.
Verified September 2013 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: September 11, 2013
Last verified: September 2013
  Purpose

This population based pragmatic 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
Other: Information about 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:
  • S-LDL-cholesterol [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
  • 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, S-cholesterol, age and sex. The SCORE risk model.


Secondary Outcome Measures:
  • Life style [ Time Frame: 12 month and three years ] [ Designated as safety issue: No ]
    Patient questionnaire. Composite measure

  • Hospitalizations due to stroke [ Time Frame: Five years ] [ Designated as safety issue: No ]
    Data will be collected from computerized medical records from hospital care in the county, regional quality registry on stroke and from the In-patient registry at the National Board of Health and Welfare.

  • Hospitalizations due to revascularizations [ Time Frame: Five 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.

  • Cause-specific mortality due to myocardial infarctions and stroke [ Time Frame: Five years ] [ Designated as safety issue: No ]
    Data will be collected from the Causes of Deaths registry at the National Board of Health and Welfare.

  • Total mortality [ Time Frame: Five years ] [ Designated as safety issue: No ]
    Data will be collected the Causes of Deaths registry at the National Board of Health and Welfare.

  • Hospitalizations due to myocardial infarctions [ Time Frame: Five 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. Carotid Intima Media Thickness Carotid plaques: Total plaque area, Grey scale median (GSM)


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: April 2020
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Info about carotid ultrasound results
Information about carotid ultrasound results to patient and physician
Other: Information about carotid ultrasound results
No Intervention: No info about carotid ultrasound results
No information about carotid ultrasound results to patient and physician.

  Hide Detailed Description

Detailed Description:

This population based pragmatic 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

Background: Myocardial infarction and stroke are the primary causes of deaths. Around 50% present with potentially life-threatening symptoms or unexpected death. The majority (90-95%) are caused by modifiable factors. Statistical screening models for risk assessment to identify individuals at high CVD risk are widely used clinically and basis for pharmacological prevention and life style modification. However, the life time risk of CVD is underestimated, the accuracy in differentiating between high and intermediate risk is only modest, the majority of events (that occur in individuals at only intermediate risk) are not predicted by such models, and randomized trials which show improved results of prevention of CVD are lacking

Generally, the association between CVD risk factors and perceived risk is weak. Adherence to preventive medications and risk factor control are poor. Health care providers are unaware of this problem, and their compliance with guidelines for prevention suboptimal. The perception of risk depends on psychological and cultural factors and level of health literacy. Risk communication is increasingly recognized as important for CVD management. Visual risk messages might be more effective than verbal information

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. Their contributory role for risk stratification is unclear, and also if imaging-based identification of at-risk subjects improves the compliance to life-style modification and pharmacotherapy. Few studies have systematically evaluated image-based risk stratification and its effect on clinical outcomes and results are conflicting. Therefore large-scale RCTs targeting low or intermediate-risk adults and focus on the impact of imaging results are needed

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

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 at rural health centres and in hospitals in the towns. CIMT and plaque formation will be visualized and measured. Individuals with a stenosis ≥50% of the carotid lumen will be excluded. In a pilot study October 2012 (95 participants) 47% were classified as "high risk" of CVD based on CIMT ≥75th percentile for age and sex, or "very high risk" based on the presence of plaque

Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written information to patient and physician, including graphic presentation in colour of CIMT (1-100 percentile by age and sex) 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

Determinants of behavioural change will be explored 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. CV risk factors and life style will be monitored after one and three years. After three years (2015-2017), the ultrasonography will be repeated and information given to all participants and their physicians. Total follow-up will be five years, i.e. until 2020.

Primary outcome variables: After 1 and 3 years: CVD risk factors and lifestyle. Secondary outcome variables: 1/ After 1, 3 and 5 years: pharmacological treatments for CVD prevention. 2/ After 3 years: quality of life, CIMT and plaque parameters 3/ Within 5 years: Myocardial infarctions, stroke, revascularizing surgery, and deaths (all-cause and CVD specific). Data will be collected from all computerized medical records in the county, the national Pharmaceutical, the In-patient, and Causes of Deaths registers.

An International Advisory Board is established

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
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
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: September 11, 2013
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 April 17, 2014