Clinical Trial: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
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.
Detailed Summary:
Sponsor: North Karelia Central Hospital
Current Primary Outcome: Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound [ Time Frame: Upon screening (AAA-screening appointment, 10 minutes per patient) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: North Karelia Central Hospital
Dates:
Date Received: March 11, 2014
Date Started: March 2014
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014
