Clinical trial NCT01785589: Validation of Myocardial Perfusion Imaging
Official title: Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
cardiac nuclear medicine
myocardial perfusion imaging
invasive coronary angiography
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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
timeFrame: 2 months
Secondary outcomes:
measure: 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
timeFrame: 2 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles GB Barone-Rochette, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.