Prevalence and Screening of Abdominal Aortic Aneurysms Am... | NCT01897623

Studies
Prevalence and Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

NCT01897623

Sponsor

North Karelia Central Hospital

Status

Completed

Last Update Posted

Dec 17, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurysm

Interventions

ultrasound of aorta

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ville Vänni, General surgeon, North Karelia Central HospitalPrincipal Investigator

Lead Sponsor

North Karelia Central HospitalOTHER

Collaborators

Name	Class
Kuopio University Hospital	OTHER
Tampere University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these CAD patients, thus making screening of these patients (for AAA) more cost-efficient.

Study will be carried out as a multi-center prospective screening study. Data will be collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere University Hospital. Data consists of 200 consecutive coronary angiography patients in each hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with previously known AAA will be excluded from the study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
ultrasound of aorta	Other		Other: ultrasound of aorta

Name	Type	Description	Arm Group Labels	Other Names
ultrasound of aorta	Other		ultrasound of aorta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound		upon screening

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients with coronary artery disease

Exclusion Criteria:

Patient's denial to participate
Female Gender
Already diagnosed or treated abdominal aortic aneurysm

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Carelia Central Hospital		Joensuu	Pohjois-Karjala	80200	Finland

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided