Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Other: ultrasound of aorta

• Registration Number: NCT02086617
• Lead Sponsor: North Karelia Central Hospital

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 Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Male patients with coronary artery disease

Exclusion Criteria

• Already diagnosed or treated abdominal aortic aneurysm
• Patient's denial to participate
• Malignant disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound of aorta	ultrasound of aorta	-

Primary Outcome Measures

Name	Time	Method
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound	Upon screening (AAA-screening appointment, 10 minutes per patient)

Trial Locations

Locations (1)

North Carelia Central Hospital; 🇫🇮 Joensuu, Pohjois-Karjala, Finland