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

This study has been completed.
Oregon Heart and Vascular Institute
Brigham and Women's Hospital
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Spectrum Dynamics Identifier:
First received: October 15, 2009
Last updated: April 23, 2013
Last verified: April 2013
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 Intervention Phase
Chest Pain Radiation: low-dose imaging Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Spectrum Dynamics:

Primary Outcome Measures:
  • 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.

Enrollment: 101
Study Start Date: June 2010
Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
as above

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01135095     History of Changes
Other Study ID Numbers: SD-DSPECT002
Study First Received: October 15, 2009
Last Updated: April 23, 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 processed this record on August 23, 2017