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

Not Applicable

Completed

• Conditions: Chest Pain
• Interventions: Radiation: low-dose imaging

• Registration Number: NCT01135095
• Lead Sponsor: Spectrum Dynamics

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

Study Timeline

• Study First Submitted: 2009-10-15
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2012-06
• Study Completion: 2013-04
• Results First Submitted: 2020-11-06
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
low-dose imaging	low-dose imaging	low dose versus standard dose imaging

Primary Outcome Measures

Name	Time	Method
Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model	1 day	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.

Trial Locations

Locations (2)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Oregon Heart and Vascular Institute; 🇺🇸 Springfield, Oregon, United States