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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.
Sponsor:
Collaborators:
Oregon Heart and Vascular Institute
Brigham and Women's Hospital
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Spectrum Dynamics
ClinicalTrials.gov Identifier:
NCT01135095
First received: October 15, 2009
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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: 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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01135095

Locations
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
Investigators
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

No publications provided

Responsible Party: Spectrum Dynamics
ClinicalTrials.gov Identifier: NCT01135095     History of Changes
Other Study ID Numbers: SD-DSPECT002
Study First Received: October 15, 2009
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014