N/A
N=101
Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
Chest Pain
Bottom Line
View on ClinicalTrials.gov: NCT01135095 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model — 2.75; 2.95 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- low-dose imaging (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectrum Dynamics
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model |
2.75; 2.95 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient is referred to myocardial perfusion D-SPECT for clinical indications.
- Written informed consent is obtained by a study investigator.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01135095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.