Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography

NCT01434641 | Completed Results

• 1 other identifier: REGA-10K09
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

myocardial perfusion SPECT; wide beam reconstruction; Tc-99m sestamibi

Outcome Measures

Primary Outcomes (2)

• Myocardial Perfusion SPECT Image Quality 12 Minutes

  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/stress count density ratio is less than 3.5, the outcome is judged unfavorable.

  at 12 minutes

• Myocardial Perfusion SPECT Image Quality 16 Minutes

  SPECT image quality realized using the stress/rest single-day protocol: 16- 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/stress count density ratio is less than 3.5, the outcome is judged unfavorable.

  at 16 minutes

Secondary Outcomes (1)

• Rest/Stress Myocardial Count Density Ratio

  immediately following SPECT image processing (1 hour after the test)

Study Arms (1)

low-dose stress MPI SPECT

OTHER

Patients will receive a low-dose stress/high-dose rest protocol. Subject results are compared to archived patients undergoing a standard protocol./

Other: low-dose stress MPI SPECT

Interventions

low-dose stress MPI SPECT OTHER

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

low-dose stress MPI SPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult
• not pregnant
• suspected coronary artery disease

You may not qualify if:

• pregnant
• under 18 years of age

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

'St. Luke's-Roosevelt Hospital

New York, New York, 10025, United States

Location

Related Publications (1)

• DePuey EG, Ata P, Wray R, Friedman M. Very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT with a conventional sodium iodide camera and wide beam reconstruction processing. J Nucl Cardiol. 2012 Oct;19(5):931-44. doi: 10.1007/s12350-012-9596-8. Epub 2012 Jul 10.

  PMID: 22777525 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: E. Gordon DePuey, M.D.
• Organization: St. Luke's-Roosevelt Hospital

edepuey@chpnet.org

212-523-3400

Study Officials

• Ernest G DePuey, M.D.

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: September 15, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

US (1)