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Rubidium Elution System Performance Testing

NCT02117284 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15800

Last updated 2018-12-24

No results posted yet for this study

Summary

Rubidium is a newly approved nuclear medicine imaging drug or 'tracer' used to look at blood flow in the heart. This tracer is given using a special pump called an 'elution system' which is considered investigational. This means the device is not yet approved by Health Canada for general use, but it has been approved for use in this study. It has been used routinely in this hospital since 2010.

The purpose of this study is to confirm proper operation of the pump. It may also help identify areas for future improvement. The study data may be used for safety reporting to the Ministry of Health or to Health Canada. The study will enroll 2,400 patients in 6 hospitals across Canada. The University of Ottawa Heart Institute (UOHI) will enroll up to 1,200 patients.

Conditions

Sponsors & Collaborators

  • Jubilant DraxImage Inc.

    collaborator INDUSTRY

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Rob S Beanlands, MD · Ottawa Heart Institute Research Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117284 on ClinicalTrials.gov