Back to resultsScreening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ultrasound of aorta
Sponsored by
About this trial
This is an interventional screening trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- Male patients with coronary artery disease
Exclusion Criteria:
- Already diagnosed or treated abdominal aortic aneurysm
- Patient's denial to participate
- Malignant disease
Sites / Locations
- North Carelia Central Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ultrasound of aorta
Arm Description
Outcomes
Primary Outcome Measures
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT02086617
First Posted
March 11, 2014
Last Updated
June 25, 2014
Sponsor
North Karelia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02086617
Brief Title
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Official Title
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Karelia Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population.
Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture.
Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent.
800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
ultrasound of aorta
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
ultrasound of aorta
Primary Outcome Measure Information:
Title
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
Time Frame
Upon screening (AAA-screening appointment, 10 minutes per patient)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients with coronary artery disease
Exclusion Criteria:
Already diagnosed or treated abdominal aortic aneurysm
Patient's denial to participate
Malignant disease
Facility Information:
Facility Name
North Carelia Central Hospital
City
Joensuu
State/Province
Pohjois-Karjala
ZIP/Postal Code
80200
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
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