Cost Effectiveness and Utility of Computed Tomography Ang... | NCT00722813

Studies
Cost Effectiveness and Utility of Computed Tomography Angiography (CTA) and Cardiac Cath

NCT00722813

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Nov 21, 2013Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

Heart Diseases

Interventions

Survey

Countries

United States

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

Nov 2013

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

Oct 2006

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 28, 2008Estimated

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

Nov 20, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.

Detailed Description

This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	To determine patient preference for the two tests CT angiography (CTA) and catheter coronary angiography (CCA).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Utility of CT and catheter angiography	Utility of CT and catheter angiography was compared within patients who had both tests performed.	Within 6 months of testing with CT and catheter angiography

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have had both CTA and Coronary angiogram.
18 years old and older.

Exclusion Criteria:

Under 18 years of age
Memory Impairment:
- Stroke
- Traumatic brain Injury
- Dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who have had both CTA and Cardiac catherizations

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aine Kelly, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Health Systems		Ann Arbor	Michigan	48109	United States

ID	Term
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided