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Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI) (Rb-ARMI)

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ClinicalTrials.gov Identifier: NCT01128023
Recruitment Status : Active, not recruiting
First Posted : May 21, 2010
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rob Beanlands, Ottawa Heart Institute Research Corporation

Brief Summary:

Cardiovascular (CV) disease is the leading cause of death in Canada. Fifty percent of all Tc-99m used in nuclear medicine is for the diagnosis of coronary artery disease (CAD) with SPECT myocardial perfusion imaging (MPI). The reduced supply of Tc-99m requires other tracers to be investigated. Tl-201 SPECT is available but generally accepted to be inferior to Tc-99m. Rubidium (Rb-82), a nonreactor produced tracer, is believed to have superior accuracy compared to Tc-99m and Tl-201 SPECT, with 5-20 times lower radiation dose. In the U.S. Rb-82 generators have been FDA-approved since 1989 and are used increasingly for CAD diagnosis, but are still considered investigational in Canada.

Objectives: To demonstrate that Rb-82 PET MPI is i) an accurate, cost-effective alternative to Tc-99m; ii) superior to Tl-201; iii) can be implemented in multiple Canadian centres for the diagnosis and management of CAD. Short term clinical outcomes of Rb-82 will be evaluated and compared to Tc-99m and Tl-201 SPECT MPI across Canadian imaging centres.

Plan: Rb-ARMI is an innovative multidisciplinary, multi-centre imaging research initiative that builds on existing collaborative networks and Canadian industry partnership (DRAXIMAGE). Rb PET will be implemented, standardized and validated in 4 overlapping phases over 2 years, at 10 Canadian Centres.

Impact: This project meets the expected goal to "lead to clinical trial applications and clinical validation studies which compare novel radiolabeled probes with those in current practice", and to "bring a new radiopharmaceutical to the clinic" within a short time frame. Increased use of Rb-82 PET MPI has the potential to reduce the demand for Tc-99m by 10-40%, effectively increasing the available supply for other procedures, and improving the standard of care for many Canadians at risk of heart disease.


Condition or disease Intervention/treatment
Coronary Artery Disease Other: Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI)
Study Start Date : April 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rubidium

Group/Cohort Intervention/treatment
PET Rb-82 perfusion imaging
Patients diagnosed with or suspected coronary artery disease requiring evaluation and/or risk stratification will undergo PET Rb-82 perfusion imaging.
Other: Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT
Patients will undergo a clinically indicated PET Rb-82 myocardial perfusion scan for diagnosis or risk stratification of CAD. This cohort will be matched to the SPECT perfusion database.

SPECT perfusion imaging
Patients diagnosed with or suspected coronary artery disease who have undergone SPECT myocardial perfusion imaging.
Other: Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT
Patients will undergo a clinically indicated PET Rb-82 myocardial perfusion scan for diagnosis or risk stratification of CAD. This cohort will be matched to the SPECT perfusion database.




Primary Outcome Measures :
  1. The accuracy of rubidium-82 PET MPI for the diagnosis of CAD will be compared to Tc-99m and Tl-201 SPECT. [ Time Frame: Baseline ]
    Accuracy of an abnormal PET and SPECT MPI, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios will be determined in the angiography cohorts using ICA as the gold standard. The primary analysis will be for an abnormal MPI defined as Sum Stress Score ≥4 or Sum Difference Score ≥2.


Secondary Outcome Measures :
  1. Evaluate the short-term resource utilization, costs and cost-effectiveness of rubidium-82 PET MPI for diagnosis and management of patients evaluated for CAD, compared to Tc-99m and Tl-201 SPECT [ Time Frame: 6 months ]
    Telephone follow-up will occur at 6 months to assess economic and clinical outcomes. Economic measures of post-MPI resource utilization include the occurrence and frequency of diagnostic, and therapeutic procedures, cardiac hospitalization, and out-patient consultations. Clinical outcomes will be the time to occurrence of the first composite clinical endpoint (described below); and occurrence of the composite endpoint; individual components of the composite endpoint and functional capacity.

  2. To evaluate the short-term clinical outcomes of rubidium-82 PET MPI for diagnosis and management of CAD, compared to Tc-99m and Tl-201 SPECT [ Time Frame: 6 months ]
    Clinical Outcomes (4B): A multivariate Cox proportional hazard model will be used to assess the annual occurrence of the composite endpoint between the imaging approaches and between reference and additional sites, in the presence of the other covariates listed above. The proportional hazards assumption underlying the model will be assessed, and if the assumption does not hold an appropriate time dependent covariate will be included in the model. Evaluation of clinical outcomes as a primary endpoint would require longer follow-up than this RFA enables.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for a clinically indicated PET Rb-82 myocardial perfusion scan.
Criteria

Inclusion Criteria:

  • patients referred for myocardial perfusion imaging for diagnosis and/or risk stratification for CAD
  • male or female
  • 18 years of age or older
  • having given informed consent

Exclusion Criteria:

  • contraindications to dipyridamole radionuclide imaging including
  • severe reactive airway disease
  • <3 days post MI/acute coronary syndrome (ACS) presentation
  • unstable crescendo angina
  • high grade atrio-ventricular (AV) block
  • allergy to dipyridamole or theophyllines
  • caffeine within 24 hours
  • theophyllines within 48 hours
  • severe claustrophobia
  • patients who may be pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128023


Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Rob S Beanlands, MD Ottawa Heart Institute Research Corporation

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rob Beanlands, Rob Beanlands, Chief Division of Cardiology, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01128023     History of Changes
Other Study ID Numbers: 211897
211897 ( Other Identifier: Canadian Institutes of Health Research )
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Rob Beanlands, Ottawa Heart Institute Research Corporation:
myocardial perfusion imaging
rubidium-82
medical isotope production
Positron emission tomography
clinically useful

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action