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

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-dose imaging
Sponsored by
Spectrum Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Myocardial perfusion, Low radiation dose, Single photon emission computed tomography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Oregon Heart and Vascular Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low-dose imaging

Arm Description

low dose versus standard dose imaging

Outcomes

Primary Outcome Measures

Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model
SRS is used to quantify presence/severity of SPECT rest myocardial perfusion defects, as assessed by visual analysis using American Heart Association (AHA) 17 segment polar map model; each segment correlates to a myocardial location. Perfusion abnormalities can be determined in relation to myocardial segment/s affected by ischemia and the perfusion defect severity scored using 0 - 4 scale for each segment (0, normal uptake; 1, mildly reduced uptake; 2, moderately reduced uptake; 3, severely reduced uptake; and 4, no uptake). SRS is calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores > 0 indicate increasingly worse outcomes as the score increases. For each patient, SRS will be compared between standard-low-dose (SLD) imaging from a conventional A-SPECT camera and ultra-low-dose (ULD) imaging from a high-efficiency D-SPECT camera, both acquired on the same day.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2009
Last Updated
January 5, 2021
Sponsor
Spectrum Dynamics
Collaborators
Oregon Heart and Vascular Institute, Brigham and Women's Hospital, Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01135095
Brief Title
Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Dynamics
Collaborators
Oregon Heart and Vascular Institute, Brigham and Women's Hospital, Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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 Tomography; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.
Detailed Description
as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Myocardial perfusion, Low radiation dose, Single photon emission computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-dose imaging
Arm Type
Experimental
Arm Description
low dose versus standard dose imaging
Intervention Type
Radiation
Intervention Name(s)
low-dose imaging
Other Intervention Name(s)
low dose imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model
Description
SRS is used to quantify presence/severity of SPECT rest myocardial perfusion defects, as assessed by visual analysis using American Heart Association (AHA) 17 segment polar map model; each segment correlates to a myocardial location. Perfusion abnormalities can be determined in relation to myocardial segment/s affected by ischemia and the perfusion defect severity scored using 0 - 4 scale for each segment (0, normal uptake; 1, mildly reduced uptake; 2, moderately reduced uptake; 3, severely reduced uptake; and 4, no uptake). SRS is calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores > 0 indicate increasingly worse outcomes as the score increases. For each patient, SRS will be compared between standard-low-dose (SLD) imaging from a conventional A-SPECT camera and ultra-low-dose (ULD) imaging from a high-efficiency D-SPECT camera, both acquired on the same day.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is referred to myocardial perfusion D-SPECT for clinical indications. Written informed consent is obtained by a study investigator. Exclusion Criteria: Patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock. Patient is diagnosed as having uncontrolled hypertension with resting blood pressure > 220 mm Hg systolic or 110 mm Hg diastolic. Patient pregnancy (known or suspected). Lack of written informed consent Prisoner status Minors under the age of 18 as coronary artery disease is generally an adult disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Einstein, MD,PHD
Organizational Affiliation
Columbia University Medical Center, Department of Medicine, Division of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Berman, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
00000
Country
United States
Facility Name
Oregon Heart and Vascular Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
00000
Country
United States

12. IPD Sharing Statement

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

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