Trial Outcomes & Findings for Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease (NCT NCT01135095)

Last Updated: 2021-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

1 day

Results posted on

2021-01-26

Participant Flow

101 patients prospectively enrolled at 3 US hospital sites (Cedars-Sinai Medical Center, Oregon Heart and Vascular Institute, Brigham and Women's Hospital) between June 2010 and June 2012.

No post-enrollment pre-assignment significant events occurred.

Participant milestones

Participant milestones
Measure	Low-dose Imaging Low-dose versus standard-dose imaging 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.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-dose Imaging n=101 Participants Low-dose versus standard dose imaging 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.
Age, Continuous	63.8 years STANDARD_DEVIATION 11.3 • n=101 Participants
Sex: Female, Male Female	47 Participants n=101 Participants
Sex: Female, Male Male	54 Participants n=101 Participants
Region of Enrollment United States	101 participants n=101 Participants
BMI	26.1 Kg/m^2 STANDARD_DEVIATION 2.8 • n=101 Participants
Diabetes Mellitus	26 Participants n=101 Participants
Hypertension	74 Participants n=101 Participants
Hyperlipidemia	77 Participants n=101 Participants
Current smoker	13 Participants n=101 Participants
Family history of premature heart disease	31 Participants n=101 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Patients with suspected or known coronary artery disease scheduled to undergo rest-stress 1 day 99mTc-based SPECT myocardial perfusion imaging.

Outcome measures

Outcome measures
Measure	Low-dose Imaging n=101 Participants Low-dose versus standard dose imaging 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
Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model Summed Rest Score Ultra-Low-Dose High-Efficiency SPECT imaging: D-SPECT camera	2.75 score on a scale Standard Deviation 5.41
Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model Summed Rest Score Standard-Low-Dose A-SPECT imaging: Siemens ECAM/Symbia T6 or Philips Forte camera	2.95 score on a scale Standard Deviation 5.40

Adverse Events

Low-dose Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew J. Einstein

Department of Medicine, Cardiology Division, Columbia University Medical Center and New York Presbyterian Hospital, New York

Phone: +1 212 305-4275

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place