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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by St. Luke's-Roosevelt Hospital Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01434641
First received: August 29, 2011
Last updated: September 14, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: myocardial perfusion SPECT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial SPECT

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Myocardial perfusion SPECT image quality [ Time Frame: immediately following SPECT image processing (1 hour after the test) ] [ Designated as safety issue: No ]

    Myocardial perfusion SPECT iamge quality is determined by visual inspection of the processed images. Criteria used include uniformity of the myocardium, definition of the endocardial and epicardial borders, definition of the valve plane, background activity, and visualization of the right ventricle.

    Please not that patient outcomes are NOT measured in this research protocol.



Secondary Outcome Measures:
  • rest/stress myocardial count density ratio [ Time Frame: immediately following SPECT image processing (1 hour after the test) ] [ Designated as safety issue: No ]

    The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.

    Please not that patient outcomes are NOT measured in this research protocol.



Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: myocardial perfusion SPECT
    novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult
  • not pregnant
  • suspected coronary artery disease

Exclusion Criteria:

  • pregnant
  • under 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434641

Contacts
Contact: Ernest G DePuey, M.D. 212-523-3398 edepuey@chpnet.org
Contact: Maritza Velez 212-523-3400 mavelez@chpnet.org

Locations
United States, New York
`St. Luke's-Roosevelt Hospital Recruiting
New York, New York, United States, 10025
Contact: Emilla Sordillo, MD    212-523-5793    esordill@chpnet.org   
Principal Investigator: Ernest G DePuey, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Ernest G DePuey, M.D. St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01434641     History of Changes
Other Study ID Numbers: REGA-10K09
Study First Received: August 29, 2011
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
myocardial perfusion SPECT
wide beam reconstruction
Tc-99m sestamibi

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014