NCT01519973

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

July 15, 2011

Last Update Submit

April 21, 2017

Conditions

Coronary Artery Disease

Keywords

Diagnostic imagingSingle Photon Emission Computed TomographyPositron emission tomographyComputed tomographyAttenuationResolutionScatterRadiopharmaceutical

Outcome Measures

Primary Outcomes (1)

  • • 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 Outcomes (4)

  • Determine the incremental benefit of AC/SC/RR compared to AC alone

    2 years

  • Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time.

    2 years

  • Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT).

    2 years

  • 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

Study Arms (1)

Evaluation of technology in SPECT

OTHER

Evaluation of the accuracy of SPECT with new technologies for attenuation correction (AC), scatter correction (SC) and resolution recovery (RR) for assessment of myocardial perfusion using Rb-82 PET as the gold standard.

Radiation: SPECT/CT processed with Evolution for CardiacTM software

Interventions

SPECT/CT processed with Evolution for CardiacTM softwareRADIATION

SPECT/CT to be compared with PET/CT

Evaluation of technology in SPECT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy and breast feeding
  • Severe narrowing (stenosis) of the aortic valve
  • Severe heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22527797RESULT

  • 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/s12350-013-9738-7. Epub 2013 Jun 5.

    PMID: 23737161RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Biological Evolution

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Genetic PhenomenaBiological Phenomena

Study Officials

  • Terrence D Ruddy, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Terrence Ruddy, MD

Study Record Dates

First Submitted

July 15, 2011

First Posted

January 27, 2012

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

This trial has concluded and the investigators have published from the available data.

Locations

CA(1)