Reducing Radioisotope Dose: the Half-Dose CZT Study

Study Overview
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Brief Summary
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This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.

Detailed Description
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The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera. The proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system.

Official Title
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Reducing Radioisotope Dose in Regadenoson SPECT Myocardial Perfusion Imaging: Comparison of Half-Dose Scans Using a Novel Solid-State-Detector Dedicated Cardiac Camera to Full Dose Scans Acquired On Standard Equipment

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Half-dose isotope for NuclearStressTest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study suspected or known coronary artery disease written informed consent Exclusion Criteria: Evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal Participation in another investigational study within the preceding month Pregnant and/or breast-feeding female ECG evidence of left bundle branch block or paced rhythm Evidence of non-ischemic cardiomyopathy Presence of hypertrophic cardiomyopathy and/or severe valvular heart disease Severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure) Known allergy to technetium-99m Potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate < 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Half-dose isotope for NuclearStressTest<br>Intervention is Nuclear stress test of the heart. Single-arm of this study Half-dose of isotope for Nuclear stress test is group of study subjects who will do Research Nuclear stress test with half-dose of isotope that normally used for routine Nuclear stress test. Isotope is the tracer CZT (cadmium zinc telluride) that used for Nuclear stress test routinely to see the function of arteries of the heart. Patients with suspected Coronary Artery Disease who meet entry criteria undergo a research nuclear stress test using a decreased dose of isotope, using a new camera. | Other: Half-dose isotope for NuclearStressTest<br>* Half-dose of tracer or radioisotope will be used for Nuclear stress test of the heart. This is imaging test of the heart to see the function of arteries of the heart.<br>* Other names: SPECT using CZT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality of the half-dose CZT versus full dose scans |  | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiation dose/exposure of the half-dose CZT vs. full dose scans |  | 1 Week | 
| Total myocardial count activity and count rates obtained during each scan |  | 1 Week | 
| Agreement between the half-dose CZT vs. full dose scans on the presence and extent of fixed or reversible defects on a per-patient and vessel basis |  | 1 Week | 
| Agreement between the half-dose vs. full dose scans on gated data such as EF, left ventricular (LV) end-diastolic volume, LV end-systolic volume |  | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease