Chest Pain
Conditions
Keywords
Myocardial perfusion, Low radiation dose, Single photon emission computed tomography
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
Interventions
RADIATIONlow-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
Sponsors
PeaceHealth Medical Group
Brigham and Women's Hospital
Cedars-Sinai Medical Center
Spectrum Dynamics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No post-enrollment pre-assignment significant events occurred.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Low-dose Imaging | — |
|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 11.3 | — |
| BMI | 26.1 Kg/m^2 STANDARD_DEVIATION 2.8 | — |
| Current smoker | 13 Participants | — |
| Diabetes Mellitus | 26 Participants | — |
| Family history of premature heart disease | 31 Participants | — |
| Hyperlipidemia | 77 Participants | — |
| Hypertension | 74 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 101 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 54 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
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.
Time frame: 1 day
Population: Patients with suspected or known coronary artery disease scheduled to undergo rest-stress 1 day 99mTc-based SPECT myocardial perfusion imaging.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-dose Imaging | 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 |
| Low-dose Imaging | 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 5.4 |