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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01519973
Other study ID # HI Protocol #2008012-01H
Secondary ID
Status Terminated
Phase N/A
First received July 15, 2011
Last updated April 21, 2017
Start date August 2008
Est. completion date August 2012

Study information

Verified date April 2017
Source Ottawa Heart Institute Research Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. There are three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where the signal gets blurrier the further the nuclear activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and new cameras with computed tomography (CT) decrease the time needed for images to be obtained while maintaining image quality. Evaluation is needed before they become standard of care.


Recruitment information / eligibility

Status Terminated
Enrollment 64
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Intermediate to high risk patients with coronary artery disease who are scheduled for routine SPECT or PET perfusion imaging

Exclusion Criteria:

- Pregnancy and breast feeding

- Severe narrowing (stenosis) of the aortic valve

- Severe heart failure

Study Design


Intervention

Radiation:
SPECT/CT processed with Evolution for CardiacTM software
SPECT/CT to be compared with PET/CT

Locations

Country Name City State
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Wells RG, Soueidan K, Timmins R, Ruddy TD. Comparison of attenuation, dual-energy-window, and model-based scatter correction of low-count SPECT to 82Rb PET/CT quantified myocardial perfusion scores. J Nucl Cardiol. 2013 Oct;20(5):785-96. doi: 10.1007/s123 — View Citation

Wells RG, Soueidan K, Vanderwerf K, Ruddy TD. Comparing slow- versus high-speed CT for attenuation correction of cardiac SPECT perfusion studies. J Nucl Cardiol. 2012 Aug;19(4):719-26. doi: 10.1007/s12350-012-9555-4. Epub 2012 Apr 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary • Determine the accuracy of myocardial perfusion assessment using SPECT with AC/SC/RR compared to Rb-82 PET. We are proposing a study to evaluate the accuracy of SPECT with the new technologies for attenuation correction (AC), scatter compensation (SC) and resolution recovery (RR) for the assessment of myocardial perfusion in patients with heart disease using Rb-82 perfusion PET as the gold standard for comparison. 2 years
Secondary Determine the incremental benefit of AC/SC/RR compared to AC alone 2 years
Secondary Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time. 2 years
Secondary Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT). 2 years
Secondary Determine if using a single CT scan acquired at stress for attenuation correction of both stress and rest SPECT decreases the accuracy over using CT scans acquired separately at rest and stress. 2 years
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