Attenuation Corrected Cardiac SPECT Using the GE Hawkeye... | NCT00587730

Studies
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

NCT00587730

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Apr 23, 2015Estimated

Enrollment

608Actual

Phase

Phase 2Phase 3

Conditions

Cardiac Disease

Interventions

GE Attenuation Corrected Hawkeye 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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruiting or enrolling participants has halted prematurely and will not resume.

Expanded Access Info

Start Date

Jul 2001

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 7, 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

Apr 21, 2015

Last Update Posted Date

Apr 23, 2015Estimated

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 accuracy of stress single photon emission computed tomography (SPECT) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress SPECT. These patients will undergo SPECT imaging both with conventional methodology and the GE Hawkeye system. The conventional study will be interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. The primary study hypothesis is that AC will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (MI). Clinical data and noninvasive test results (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to MI (true-positive).

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

608Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinical SPECT	Active Comparator	GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.	Device: GE Attenuation Corrected Hawkeye Camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GE Attenuation Corrected Hawkeye Camera	Device	GE Hawkeye AC system and 360˚ camera orbit	Clinical SPECT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test.		Measured/Compared at time of each scan.

Secondary Outcomes

Measure	Description	Time Frame
Comparisons of categorical factors between the 2 tests will also be completed using McNemar's test, continuous factors will be completed using a paired t-test if the differences are normally distributed.		Measured/Compared at time of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients referred to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT

Exclusion criteria:

Prior PTCA or CABG
Left bundle branch block (LBBB) or paced ventricular rhythm
Clinically significant valvular heart disease
Hypertrophic or idiopathic dilated cardiomyopathy
Atrial fibrillation or frequent atrial or ventricular ectopy (defined as >20% ectopic beats
History of MI
ECG evidence of MI
Chest circumference >55 inches

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Todd D Miller, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D002637	Chest Pain
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

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Browse Branches

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