Validation of Myocardial Perfusion Imaging

NCT ID: NCT01785589

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

coronary angiography

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles GB Barone-Rochette, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital

Grenoble, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25381092 (View on PubMed)

Other Identifiers

IRB 5891

Identifier Type: -

Identifier Source: org_study_id