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

Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135095
• Other study ID #: SD-DSPECT002
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: January 2021
• Source: Spectrum Dynamics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

as above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Oregon Heart and Vascular Institute	Springfield	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Spectrum Dynamics	Brigham and Women's Hospital, Cedars-Sinai Medical Center, Oregon Heart and Vascular Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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