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NCT01434641 · ClinicalTrials.gov registry record · NA
Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography
A NA study of Coronary Artery Disease, sponsored by St. Luke's-Roosevelt Hospital Center.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT01434641: Completed NA study of Coronary Artery Disease, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT01434641 is a NA study of Coronary Artery Disease that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 102 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01434641, a NA study of Coronary Artery Disease, has completed, sponsored by St. Luke's-Roosevelt Hospital Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is \> 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is "poor" or if the rest/str
Conditions Studied
Interventions
- OTHER low-dose stress MPI SPECT
Study Locations (1)
New York
- 'St. Luke's-Roosevelt Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-03 |
| Phase | NA |
What the finished NCT01434641 record still lists
NCT01434641 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which low-dose stress MPI SPECT is the first listed.
NCT01434641 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01434641 about?
NCT01434641 is a clinical study titled "Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography". 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 Recons...
What is the current status of trial NCT01434641?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2011-07. Estimated completion is 2012-03.
What conditions does trial NCT01434641 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01434641?
The interventions under investigation include: low-dose stress MPI SPECT (OTHER).
Who is sponsoring clinical trial NCT01434641?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01434641 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01434641's enrollment target sits among peer trials
102 147th of 219 higher than 71 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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