NCT01993303

Brief Summary

Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (\~20 mCi) processed using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage (\~50 mCi) 2D Rb-82 PET MPI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2004

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

8.3 years

First QC Date

August 1, 2012

Last Update Submit

November 20, 2013

Conditions

Coronary Artery Disease

Keywords

Myocardial Perfusion ImagingPETRb-82

Outcome Measures

Primary Outcomes (2)

  • Quantitative Accuracy

    To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.

    1 day

  • Visual Assessment

    To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.

    1 day

Study Arms (1)

Single Cohort

Population: 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Radionuclide Dosage: Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi All were stress with Dipyridamole.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male.

You may qualify if:

  • \>18 Years of Age
  • Have ability to provide informed consent
  • Have a technically adequate rest/stress Rb-82 perfsion PET study within the past 60 days

You may not qualify if:

  • Pregnant or nursing feamle
  • Weight \> 275 lbs
  • Have contraindications to adenosine stress testing
  • Unstable cardiac rhythm (atrial fibrillation, frequent PVCs
  • PTCA or CABG within the last 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Lukes Hospital

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

November 25, 2013

Study Start

January 1, 2004

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

US(1)