N/A
N=102
Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01434641 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
Apr 2016
Primary outcome: Primary: Myocardial Perfusion SPECT Image Quality 12 Minutes — 1; 0; 8; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- low-dose stress MPI SPECT (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Perfusion SPECT Image Quality 12 Minutes |
1; 0; 8; 3; 30; 20 | — |
| PRIMARY Myocardial Perfusion SPECT Image Quality 16 Minutes |
0; 0; 1; 1; 7; 7 | — |
| SECONDARY Rest/Stress Myocardial Count Density Ratio |
— | — |
Summary
This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during exercise or regadenoson pharmacologic stress and undergo a full-time SPECT acquisition processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients receive a high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest scan, also processed with WBR. All enrolled research subjects will undergo both the initial stress and subsequent rest scan.
The radiation exposure associated with this new stress/rest protocol is equivalent to that of the conventional rest/stress protocol presently in routine clinical uses at SLRHC.
Eventually, when and if this novel stress/rest protocol is adopted in routine clinical practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi (331 mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear Medicine Laboratory.
All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or suspected coronary artery disease will be candidates for enrollment. Fifty patients undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.
Eligibility Criteria
Inclusion Criteria
- adult
- not pregnant
- suspected coronary artery disease
Exclusion Criteria
- pregnant
- under 18 years of age
Data sourced from ClinicalTrials.gov (NCT01434641). 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.