Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086617
• Other study ID #: AAA-CAD-04
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: June 25, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Primary Purpose: Screening

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• ultrasound of aorta

Locations

Country	Name	City	State
Finland	North Carelia Central Hospital	Joensuu	Pohjois-Karjala

Sponsors (1)

Lead Sponsor	Collaborator
North Karelia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound		Upon screening (AAA-screening appointment, 10 minutes per patient)	No