Screening Cardiovascular Patients for Aortic Aneurysms (SCAN)

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 27, 2014