Screening Cardiovascular Patients for Aortic Aneurysms (SCAN)

This study is currently recruiting participants.
Verified May 2013 by Catharina Ziekenhuis Eindhoven
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01643317
First received: July 16, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness of screening for AAA in men in the Netherlands has been demonstrated by using a Markov model. Screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an AAA.

Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. This pilot project aims to study the value of a screening protocol in daily practice to detect AAA's in high risk patients.


Condition
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Cardiovascular Patients for Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • AAA prevalence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:
  1. Offering PAD and CAD patients a non-invasive abdominal ultrasound after a careful process of shared-decision making
  2. Recording data on aneurysm detection on all PAD and CAD patients screened:

    1. General information (age, gender)
    2. Medical history on CardioVascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart)
    3. AAA - Yes/ No (Yes if ≥3 cm AAA)
    4. If ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment)
    5. If treated, record treatment type (EVAR or Open) and outcome
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with peripheral arterial disease or carotid arterial disease

Criteria

Inclusion Criteria:

  • male and female patients
  • peripheral arterial disease (ankle brachial index < 0,90 and/or reduction of > 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%)
  • age > 55 year

Exclusion Criteria:

  • Patients unfit for endovascular or open surgery (as judged by vascular surgeon)
  • Failure to master the dutch language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643317

Locations
Netherlands
Catharina Hospital Recruiting
Eindhoven, Netherlands
Contact: Nicole Verhofstad, PhD    0031 402396349    nicole.verhofstad@catharinaziekenhuis.nl   
Principal Investigator: Joep Teijink, MD, PhD         
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: Joep Teijink, MD, PhD, Vascular Surgeon, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01643317     History of Changes
Other Study ID Numbers: Catharina_Project_SCAN
Study First Received: July 16, 2012
Last Updated: May 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014