CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
low-dose stress MPI SPECTother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01434641
NCT01434641N/ACompleted

Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial SPECT

St. Luke's-Roosevelt Hospital Center·interventional·Posted Sep 15, 2011·Updated Apr 11, 2016

In Brief

A clinical study evaluating low-dose stress MPI SPECT for Coronary Artery Disease. Completed, enrolled 102 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2011
Enrollment StartJul 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.8 years ago

Interventions

low-dose stress MPI SPECTother

novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing