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Reducing Radioisotope Dose: the Half-Dose CZT Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01518777
Recruitment Status : Recruiting
First Posted : January 26, 2012
Last Update Posted : February 9, 2017
The Methodist Hospital System
Information provided by (Responsible Party):
S.M.Chang, MD, The Methodist Hospital System

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Half-dose isotope for NuclearStressTest Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Half-dose isotope for NuclearStressTest
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
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.
Other Name: SPECT using CZT

Primary Outcome Measures :
  1. Image quality of the half-dose CZT versus full dose scans [ Time Frame: 1 Week ]

Secondary Outcome Measures :
  1. Total radiation dose/exposure of the half-dose CZT vs. full dose scans [ Time Frame: 1 Week ]
  2. Total myocardial count activity and count rates obtained during each scan [ Time Frame: 1 Week ]
  3. 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 [ Time Frame: 1 Week ]
  4. 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 [ Time Frame: 1 Week ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518777

Contact: Christopher Mattair 713-363-9956 cbmattair@houstonmethodist.og

United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Christopher Mattair    713-363-9956   
Principal Investigator: Su Min Chang, MD         
Sub-Investigator: Faisal Nabi, MD         
Sub-Investigator: Mahmarian John, MD         
Sponsors and Collaborators
S.M.Chang, MD
The Methodist Hospital System
Principal Investigator: Su Min Chang, MD The Methodist Hospital System


Responsible Party: S.M.Chang, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System Identifier: NCT01518777     History of Changes
Other Study ID Numbers: Pro00006818
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined.

Keywords provided by S.M.Chang, MD, The Methodist Hospital System:
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases