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

NCT01135095 | Completed Results

• 1 other identifier: SD-DSPECT002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

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.

Conditions

Chest Pain

Keywords

Myocardial perfusion; Low radiation dose; Single photon emission computed tomography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

low-dose imaging

EXPERIMENTAL

low dose versus standard dose imaging

Radiation: low-dose imaging

Interventions

low-dose imaging RADIATION

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

Also known as: low dose imaging

low-dose imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectrum Dynamics: lead
• PeaceHealth Medical Group: collaborator
• Brigham and Women's Hospital: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 00000, United States

Location

Oregon Heart and Vascular Institute

Springfield, Oregon, 00000, United States

Location

MeSH Terms

Conditions

Chest Pain

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Dr. Andrew J. Einstein
• Organization: Department of Medicine, Cardiology Division, Columbia University Medical Center and New York Presbyterian Hospital, New York

Andrew.einstein@columbia.edu

+1 212 305-4275

Study Officials

• Andrew Einstein, MD,PHD

  Columbia University Medical Center, Department of Medicine, Division of Cardiology

  PRINCIPAL INVESTIGATOR

• Dan Berman, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Locations

US (2)