Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark

February 24, 2016 updated by: Central Jutland Regional Hospital

Well-documented health benefits may be achieved through prophylactic screening for cardiovascular disease. The advantages are fewer premature deaths and a reduction in the number of hospital admissions and amputations. Furthermore, hospitals will benefit from the derived reduction in the pressure on surgery and intensive care capacities at vascular surgery departments.

It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm, peripheral arterial disease and hypertension, even if the benefit and costs of such a measure are not currently known.

Consequently, the primary objective of the study is to establish the effect and cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in a randomised, clinically controlled study.

The project manager will train six nurses to measure ABI and perform ultrasound scans of the aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in the Region. Civil registration number (in Danish: CPR), name and address information will be supplied by the Clinical Epidemiological Department (CED), which will also perform the randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to invitation. Half of the randomised subjects will be invited to participate in a circulation examination focused on PAD, AAA and hypertension, while the other half will be controls Men with positive findings are informed and proper preventive actions is taken. Annual controls are offered, and AAA exceeding 5.5 cm in diameter is offered operation.

The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary efficiency variables are hospital services related to cardiovascular conditions and costs for such services in accordance with current DRG rates.

The entire population, the controls as well as the screening group, will be monitored for a period of 10 years. Information concerning deaths, including date of death, is obtained from the Civil Registration System, information on visits to outpatient clinics and hospital admissions caused by cardiovascular conditions including amputations is obtained from the National Patient Registry. From the Danish Causes of Death Registry information on cause of death is collected. The information is classified with regards to cause; AAA or cardiovascular. The cardiovascular interventions are identified in the vascular surgery database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.

A steering and data validation group will be formed including the project manager and a representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon from each of the two affected departments in the region will participate.

Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital service are compared for the two groups using Cox proportional hazards-regression analysis which facilitates description of the risk ratio. The cost-efficiency calculation will be adjusted for quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Viborg, Denmark, 8800
        • Recruiting
        • Vascular Research Unit, Dept. of Vasc. Surgery, Viborg Hospital
        • Principal Investigator:
          • Jes S. Lindholt, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 74 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • men aged 65-74 years old living in the central region of Denmark

Exclusion Criteria:

  • men not aged 65-74 years
  • men aged 65-74 years old not living in the central region of Denmark

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Invited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
Invited to vascular screening
No Intervention: 2
Participants which are not offered vascular screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 3, 5, and 10 years
3, 5, and 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular events
Time Frame: 3,5 and 10 years
3,5 and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Jutland Regional Hospital

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Jes S. Lindholt, M.D.,Ph.D., Vascular Research Unit, Viborg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20080028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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