Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI

NCT ID: NCT01373944

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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MPI SPECT Stress-Only Spectrum Dynamics Camera Anger

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stress Only SPECT MPI with Anger Camera

Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the traditional Anger camera

No interventions assigned to this group

Stress Only SPECT MPI with SD Camera

Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the Spectrum Dynamics camera system.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* BMI \< 35 kg/m2
* LVEF \> 40%
* Exercise stress
* Elective out-patients
* No known CAD (\>50%) by catheterization
* No history of prior myocardial infarction

Exclusion Criteria

* LBBB
* Pacemaker
* Atrial Fibrillation
* Frequent PAC's or PVC's
* Inability to achieve at least 6 minutes
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Dynamics

INDUSTRY

Sponsor Role collaborator

Cardiovascular Imaging Technologies, LLC

UNKNOWN

Sponsor Role collaborator

Saint Luke's Cardiovascular Consultants

OTHER

Sponsor Role collaborator

Mid America Heart Institute

OTHER

Sponsor Role collaborator

Aspire Foundation

OTHER

Sponsor Role lead

Responsible Party

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Aspire Foundation

Principal Investigators

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Timothy M Bateman, MD

Role: PRINCIPAL_INVESTIGATOR

Aspire Foundation

Locations

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Saint Luke's Cardiovascular Imaging Center

Kansas City, Missouri, United States

Site Status

Saint Luke's North Cardiovascular Imaging Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East Cardiovascular Imaging Center

Lee's Summit, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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D-Spect Stress Only

Identifier Type: -

Identifier Source: org_study_id