Viewing Study NCT02086617



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Study NCT ID: NCT02086617
Status: COMPLETED
Last Update Posted: 2014-06-26
First Post: 2014-03-11

Brief Title: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Sponsor: North Karelia Central Hospital
Organization: North Karelia Central Hospital

Study Overview

Official Title: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Status: COMPLETED
Status Verified Date: 2014-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ClinicalTrialsgov 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None