ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening Cardiovascular Patients for Aortic Aneurysms (SCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01643317
Recruitment Status : Unknown
Verified May 2013 by Joep Teijink, Catharina Ziekenhuis Eindhoven.
Recruitment status was:  Recruiting
First Posted : July 18, 2012
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, Catharina Ziekenhuis Eindhoven

Brief Summary:

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 or disease
Abdominal Aortic Aneurysm

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

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Cardiovascular Patients for Aortic Aneurysms
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. AAA prevalence [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

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