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

Validation of a Low-Dose One-Day TC99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera for Detection of Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Radiation: low-dose imaging

Detailed Description

as above

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 00000
      • Cedars-Sinai Medical Center
  • Oregon
    • Springfield, Oregon, United States, 00000
      • Oregon Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: low dose imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Spectrum Dynamics
• Collaborators: Brigham and Women's Hospital; Cedars-Sinai Medical Center; Oregon Heart and Vascular Institute
• 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

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Myocardial perfusion; Single photon emission computed tomography; Low radiation dose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: SD-DSPECT002