search
Back to results

Validation of Myocardial Perfusion Imaging (CameraCZT)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
coronary angiography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, cardiac nuclear medicine, myocardial perfusion imaging, invasive coronary angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable angina
  • Cadmium-zinc-telluride gamma camera SPECT with dual isotope imaging
  • Coronarography

Exclusion Criteria:

  • Pregnant woman
  • Patient with terminal illness,
  • Terminal Renal failure
  • Allergy to iodine

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

coronary angiography-FFR-CZT

Arm Description

Patients who were referred to our cardiology department for stress-rest CZT SPECT for known or suspected CAD and submitted for a clinical reason to invasive coronary angiography within 2 month of the SPECT studies. for these patients, A 6 French arterial sheath was introduced into the radial artery. After administration of 5000 U heparin, the guiding catheter was advanced into the coronary ostium. Intracoronary nitroglycerin 0.2 mg was administered, and reference images were made. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease. If necessary (at the discretion of the practitioner) the pressure wire was advanced across the stenosis, and Fractional flow reserve (FFR) was measured.

Outcomes

Primary Outcome Measures

Accuracy, positive and negative predictive value of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease
Diagnostic performance of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease is evaluated vs. coronary angiography. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease in coronary angiography. In CZT SPECT, The global summed stress score (SSS) summed rest score (SRS) and summed difference score (SDS) were calculated by adding the scores of the 17 segments in the stress and rest images, respectively. Significant ischemia is defined by SSS >4. Analyze is performed per patients, per segments, and per vessels.

Secondary Outcome Measures

Accuracy, positive and negative predictive value of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease
Diagnostic performance of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease is evaluated vs. Fractional Flow reserve (FFR). Significant CAD was defined as presentation of a stenosis with FFR ≤ 0.8 in the three-epicardial vessels and in left main coronary disease. In CZT SPECT, The global summed stress score (SSS) summed rest score (SRS) and summed difference score (SDS) were calculated by adding the scores of the 17 segments in the stress and rest images, respectively. Significant ischemia is defined by SSS >4. Analyze is performed per patients, per segments, and per vessels.

Full Information

First Posted
January 29, 2013
Last Updated
May 27, 2015
Sponsor
University Hospital, Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT01785589
Brief Title
Validation of Myocardial Perfusion Imaging
Acronym
CameraCZT
Official Title
Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.
Detailed Description
The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. Indeed, recent clinical validation studies of CZT technology have documented a scan time reduction and low radiation dose without degradation of myocardial perfusion imaging in comparison with standard dual detector cameras. The increased photon counting sensitivity of camera can be used to explore novel protocols that may offer advantages over standard protocols used for Myocardial Perfusion Imaging. Berman et al. showed that rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI has offered the superior qualities of Tl-201 for stress imaging and of the Tc-99m agents for rest imaging can be preserved. Nuclear medicine presents the most level of scientific validation for diagnosis and prognosis of coronary artery disease. A lot of studies have compared performance of standard dual detector cameras vs. Invasive Coronary Angiography. Fiechter et al. reported the first validation of ultrafast dedicated cardiac gamma camera with CZT versus invasive coronary angiography. But he used a novel hybrid SPECT /CT device and 99m-Tc-tetrofosmin pharmacological stress/rest examination. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. Moreover, diagnosis performance of this high-speed protocol versus fractional flow reserve for stenosis evaluation is unknown. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive procedures (coronary angiography and fractional flow reserve) as the standard of reference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, cardiac nuclear medicine, myocardial perfusion imaging, invasive coronary angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
coronary angiography-FFR-CZT
Arm Type
Other
Arm Description
Patients who were referred to our cardiology department for stress-rest CZT SPECT for known or suspected CAD and submitted for a clinical reason to invasive coronary angiography within 2 month of the SPECT studies. for these patients, A 6 French arterial sheath was introduced into the radial artery. After administration of 5000 U heparin, the guiding catheter was advanced into the coronary ostium. Intracoronary nitroglycerin 0.2 mg was administered, and reference images were made. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease. If necessary (at the discretion of the practitioner) the pressure wire was advanced across the stenosis, and Fractional flow reserve (FFR) was measured.
Intervention Type
Procedure
Intervention Name(s)
coronary angiography
Other Intervention Name(s)
Coronary angiography = using standard techniques (Philips Allura Xper FD10, Philips Healthcare), Pressure wire = Certus; St. Jude Medical, St. Paul, Minnesota, FFR by using RadiAnalyzer =St. Jude Medical, St. Paul, Minnesota), intravenous adenosine = ADENOSCAN 30mg/10ml S perf IV 6Fl/10ml (Sanofi-Aventis France)
Intervention Description
A 6 French arterial sheath was introduced into the radial artery. After administration of 5000 U heparin, the guiding catheter was advanced into the coronary ostium. Intracoronary nitroglycerin 0.2 mg was administered, and reference images were made. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease. If necessary (at the discretion of the practitioner) the pressure wire was advanced across the stenosis, and Fractional flow reserve (FFR) was measured.
Primary Outcome Measure Information:
Title
Accuracy, positive and negative predictive value of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease
Description
Diagnostic performance of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease is evaluated vs. coronary angiography. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease in coronary angiography. In CZT SPECT, The global summed stress score (SSS) summed rest score (SRS) and summed difference score (SDS) were calculated by adding the scores of the 17 segments in the stress and rest images, respectively. Significant ischemia is defined by SSS >4. Analyze is performed per patients, per segments, and per vessels.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Accuracy, positive and negative predictive value of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease
Description
Diagnostic performance of Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging to detect coronary artery disease is evaluated vs. Fractional Flow reserve (FFR). Significant CAD was defined as presentation of a stenosis with FFR ≤ 0.8 in the three-epicardial vessels and in left main coronary disease. In CZT SPECT, The global summed stress score (SSS) summed rest score (SRS) and summed difference score (SDS) were calculated by adding the scores of the 17 segments in the stress and rest images, respectively. Significant ischemia is defined by SSS >4. Analyze is performed per patients, per segments, and per vessels.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable angina Cadmium-zinc-telluride gamma camera SPECT with dual isotope imaging Coronarography Exclusion Criteria: Pregnant woman Patient with terminal illness, Terminal Renal failure Allergy to iodine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles GB Barone-Rochette, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25381092
Citation
Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Celine GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.
Results Reference
derived

Learn more about this trial

Validation of Myocardial Perfusion Imaging

We'll reach out to this number within 24 hrs