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

NCT01128023 | Completed

• 1 other identifier: 211897
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

myocardial perfusion imaging; rubidium-82; medical isotope production; Positron emission tomography; clinically useful

Outcome Measures

Primary Outcomes (1)

• The accuracy of rubidium-82 PET MPI for the diagnosis of CAD will be compared to Tc-99m and Tl-201 SPECT.

  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.

  Baseline

Secondary Outcomes (2)

• 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

  6 months

• 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

  6 months

Study Arms (2)

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

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

Interventions

Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT OTHER

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.

PET Rb-82 perfusion imaging; SPECT perfusion imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for a clinically indicated PET Rb-82 myocardial perfusion scan.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (3)

• Kaster T, Mylonas I, Renaud JM, Wells GA, Beanlands RS, deKemp RA. Accuracy of low-dose rubidium-82 myocardial perfusion imaging for detection of coronary artery disease using 3D PET and normal database interpretation. J Nucl Cardiol. 2012 Dec;19(6):1135-45. doi: 10.1007/s12350-012-9621-y. Epub 2012 Sep 21.

  PMID: 22996831 BACKGROUND

• Renaud JM, Mylonas I, McArdle B, Dowsley T, Yip K, Turcotte E, Guimond J, Trottier M, Pibarot P, Maguire C, Lalonde L, Gulenchyn K, Wisenberg G, Wells RG, Ruddy T, Chow B, Beanlands RS, deKemp RA. Clinical interpretation standards and quality assurance for the multicenter PET/CT trial rubidium-ARMI. J Nucl Med. 2014 Jan;55(1):58-64. doi: 10.2967/jnumed.112.117515. Epub 2013 Nov 18.

  PMID: 24249797 BACKGROUND

• Bami K, Tewari S, Guirguis F, Garrard L, Guo A, Hossain A, Ruddy TD, Beanlands RSB, deKemp RA, Chow BJW, Dwivedi G. Prognostic utility of splenic response ratio in dipyridamole PET myocardial perfusion imaging. J Nucl Cardiol. 2019 Dec;26(6):1888-1897. doi: 10.1007/s12350-018-1269-9. Epub 2018 Apr 12.

  PMID: 29651739 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Technetium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Study Officials

• Rob S Beanlands, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rob Beanlands, Chief Division of Cardiology

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 21, 2010
• Study Start: April 1, 2010
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

CA (1)