Accuracy of Half of the Usual Radiotracer Dose in SPECT

NCT01412827 | Completed

• 1 other identifier: HI Protocol #2010127-01H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

There has been a shortage of nuclear isotopes, not only in Canada but around the world. New, more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras have also shown the ability to use a smaller dose of radioisotope to obtain the images. New software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired a new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The investigators will now be looking at the quality of images using less isotope during SPECT myocardial perfusion imaging for diagnostic and prognostic purposes.

Conditions

Coronary Artery Disease

Keywords

Single-photon emission computed tomography; myocardial perfusion imaging; rest/stress; treadmill; persantine; half-dose; radiotracer; tetrofosmin; Thallium; cadmium zinc telluride; diagnostic; prognostic

Outcome Measures

Primary Outcomes (1)

• Rate of non-fatal infarction or death in the normal group of SPECT-Light acquisitions versus standard SPECT acquisitions

  The difference in the rate of non-fatal infarction or death that occurs in the normal group of the combined SPECT-Light acquisition protocols (LDa and LDb) versus the outcome that occurs in the acquisitions obtained by the standard SPECT (FD) protocol.

  2 years

Secondary Outcomes (1)

• Comparison of classification of the degree of abnormality based on the two image acquisition protocols

  2 years

Study Arms (1)

Comparison of radioisotope dosing

OTHER

Radiation: 1/2 dose of 99mTc OR 201Tl tracers

Interventions

1/2 dose of 99mTc OR 201Tl tracers RADIATION

Rest: Imaging will occur 30 to 60 minutes after injection of tracer. Stress: All patients will undergo a symptom-limited Bruce protocol treadmill exercise test. At peak stress, the radiotracer will be injected intravenously, and exercise will continue for an additional 60 s. The patients who are unable to achieve the targeted heart rate or exercise will be stressed pharmacologically. Dipyridamole (0.142 mg/kg/min) will be infused intravenously for 5 minutes, and 99mTc radiotracer will be injected at 2 min after infusion completion (7 min into the study). Aminophylline (100-200 mg) will be given intravenously 2 min after injection of the radiotracer.

Comparison of radioisotope dosing

Eligibility Criteria

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

You may qualify if:

• Consecutive patients presenting for clinically indicated SPECT perfusion scan
• Patients presenting to sites with a functional CZT camera. Available sites are Ottawa (OHI), Mississauga, and Calgary.
• Age \>18 years old

You may not qualify if:

• Patients with a life expectancy less than 1 year, from non cardiac cause
• Age \< 18 years old or lack of consent
• Allergy or contraindication to dipyridamole
• Refractory angina or infarction or need for urgent angiography
• Known pregnancy
• Uncontrolled atrial fibrillation

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

Related Publications (3)

• Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Stress myocardial perfusion single-photon emission computed tomography is clinically effective and cost effective in risk stratification of patients with a high likelihood of coronary artery disease (CAD) but no known CAD. J Am Coll Cardiol. 2004 Jan 21;43(2):200-8. doi: 10.1016/j.jacc.2003.07.043.

  PMID: 14736438 BACKGROUND

• Marcassa C, Bax JJ, Bengel F, Hesse B, Petersen CL, Reyes E, Underwood R; European Council of Nuclear Cardiology (ECNC); European Society of Cardiology Working Group 5 (Nuclear Cardiology and Cardiac CT); European Association of Nuclear Medicine Cardiovascular Committee. Clinical value, cost-effectiveness, and safety of myocardial perfusion scintigraphy: a position statement. Eur Heart J. 2008 Feb;29(4):557-63. doi: 10.1093/eurheartj/ehm607. Epub 2008 Jan 17.

  PMID: 18202253 BACKGROUND

• Beanlands RS, Chow BJ, Dick A, Friedrich MG, Gulenchyn KY, Kiess M, Leong-Poi H, Miller RM, Nichol G, Freeman M, Bogaty P, Honos G, Hudon G, Wisenberg G, Van Berkom J, Williams K, Yoshinaga K, Graham J; Canadian Cardiovascular Society; Canadian Association of Radiologists; Canadian Association of Nuclear Medicine; Canadian Nuclear Cardiology Society; Canadian Society of Cardiac Magnetic Resonance. CCS/CAR/CANM/CNCS/CanSCMR joint position statement on advanced noninvasive cardiac imaging using positron emission tomography, magnetic resonance imaging and multidetector computed tomographic angiography in the diagnosis and evaluation of ischemic heart disease--executive summary. Can J Cardiol. 2007 Feb;23(2):107-19. doi: 10.1016/s0828-282x(07)70730-4.

  PMID: 17311116 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Renée Hessian, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Renee Hessian

Study Record Dates

• First Submitted: August 7, 2011
• First Posted: August 9, 2011
• Study Start: April 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

CA (1)