Clinical trial NCT01518777: Reducing Radioisotope Dose: the Half-Dose CZT Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2012-01-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Image quality of the half-dose CZT versus full dose scans
timeFrame: 1 Week
Secondary outcomes:
measure: Total radiation dose/exposure of the half-dose CZT vs. full dose scans
timeFrame: 1 Week
measure: Total myocardial count activity and count rates obtained during each scan
timeFrame: 1 Week
measure: 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
timeFrame: 1 Week
measure: 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
timeFrame: 1 Week
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Su Min Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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