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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 : Completed
First Posted : July 18, 2012
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, Catharina Ziekenhuis Eindhoven

Tracking Information
First Submitted Date July 16, 2012
First Posted Date July 18, 2012
Last Update Posted Date July 24, 2019
Study Start Date July 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2013)
AAA prevalence [ Time Frame: 1 year ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening Cardiovascular Patients for Aortic Aneurysms
Official Title Screening Cardiovascular Patients for Aortic Aneurysms
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with peripheral arterial disease or carotid arterial disease
Condition Abdominal Aortic Aneurysm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 23, 2019)
35
Original Estimated Enrollment
 (submitted: July 17, 2012)
1
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01643317
Other Study ID Numbers Catharina_Project_SCAN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joep Teijink, Catharina Ziekenhuis Eindhoven
Study Sponsor Catharina Ziekenhuis Eindhoven
Collaborators Not Provided
Investigators Not Provided
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date July 2019