NCT02086617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

March 11, 2014

Last Update Submit

June 25, 2014

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound

    Upon screening (AAA-screening appointment, 10 minutes per patient)

Study Arms (1)

ultrasound of aorta

OTHER
Other: ultrasound of aorta

Interventions

ultrasound of aortaOTHER
ultrasound of aorta

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients with coronary artery disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carelia Central Hospital

Joensuu, Pohjois-Karjala, 80200, Finland

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

FI(1)