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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rob Beanlands, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01128023
First received: May 5, 2010
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rubidium-82 - An Alternative Radiopharmaceutical for Myocardial Imaging(Rb-ARMI)

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10000
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128023

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

No publications provided

Responsible Party: Rob Beanlands, Rob Beanlands, Chief Division of Cardiology, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01128023     History of Changes
Other Study ID Numbers: 211897, 211897
Study First Received: May 5, 2010
Last Updated: April 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
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
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014