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Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01135095
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : April 24, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomgraphy; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.

Condition or disease Intervention/treatment Phase
Chest Pain Radiation: low-dose imaging Phase 4

Detailed Description:
as above

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Low-Dose One-Day TC99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera for Detection of Coronary Artery Disease
Study Start Date : June 2010
Primary Completion Date : June 2012
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: low-dose imaging
low dose versus standard dose imaging
Radiation: low-dose imaging

The study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.

D-SPECT cardiac scanner the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient

Other Name: low dose imaging

Outcome Measures

Primary Outcome Measures :
  1. Summed Rest Score. [ Time Frame: 1 day ]
    The Summed Rest Score is a standard measure used to quantify myocardial perfusion on nuclear imaging, which takes an integer value between 0 and 68. Summed Rest Score will be compared between standard dose and low-dose protocols. Summed Rest Score will be assessed on the same day in each patient using both standard dose and low-dose protocols. Thus, two Summed rest scores will be obtained for each patient using images obtained on the same day and compared.

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient is referred to myocardial perfusion D-SPECT for clinical indications.
  2. Written informed consent is obtained by a study investigator.

Exclusion Criteria:

  1. Patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock.
  2. Patient is diagnosed as having uncontrolled hypertension with resting blood pressure > 220 mm Hg systolic or 110 mm Hg diastolic.
  3. Patient pregnancy (known or suspected).
  4. Lack of written informed consent
  5. Prisoner status
  6. Minors under the age of 18 as coronary artery disease is generally an adult disease
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01135095

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 00000
United States, Oregon
Oregon Heart and Vascular Institute
Springfield, Oregon, United States, 00000
Sponsors and Collaborators
Spectrum Dynamics
Oregon Heart and Vascular Institute
Brigham and Women's Hospital
Cedars-Sinai Medical Center
Principal Investigator: Andrew Einstein, MD,PHD Columbia University Medical Center, Department of Medicine, Division of Cardiology
Principal Investigator: Dan Berman, MD Cedars-Sinai Medical Center
More Information

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT01135095     History of Changes
Other Study ID Numbers: SD-DSPECT002
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Spectrum Dynamics:
Myocardial perfusion
Low radiation dose
Single photon emission computed tomography

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms