Validation of Myocardial Perfusion Imaging (CameraCZT)
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| First Received Date ICMJE | January 29, 2013 | ||||
| Last Updated Date | February 11, 2013 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01785589 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of Myocardial Perfusion Imaging | ||||
| Official Title ICMJE | Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Procedure: coronary angiography
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.
Other Names:
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| Study Arm (s) | coronary angiography-FFR-CZT
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: Procedure: coronary angiography |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 220 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01785589 | ||||
| Other Study ID Numbers ICMJE | IRB 5891 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Grenoble | ||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Grenoble | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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