Imaging Studies With GE C-Hawk Gamma Camera Compared to R... | NCT00256581

Studies
Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam

NCT00256581

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Aug 29, 2012Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Chest Pain

Interventions

Additional rest and stress image sets on new camera

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

Aug 2012

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

Nov 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Nov 16, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

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

Aug 28, 2012

Last Update Posted Date

Aug 29, 2012Estimated

Name	Class
General Electric	INDUSTRY

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

Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Detailed Description

Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

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

34Actual

Name	Type	Description	Arm Group Labels	Other Names
Additional rest and stress image sets on new camera	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referral for cardiac stress testing with SPECT myocardial perfusion imaging

Exclusion Criteria:

refusal to provide written informed consent or lack capacity to provide informed consent

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

Adults undergoing SPECT Myocardial perfusion imaging

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Hellman, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UW Health		Madison	Wisconsin	53715	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D002637	Chest Pain

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided