Validation of Myocardial Perfusion Imaging

NCT01785589 | Completed Phase 4 DMC

• 1 other identifier: IRB 5891
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; cardiac nuclear medicine; myocardial perfusion imaging; invasive coronary angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

• 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

  2 months

Study Arms (1)

coronary angiography-FFR-CZT

OTHER

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.

Procedure: coronary angiography

Interventions

coronary angiography 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.

Also known as: 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)

coronary angiography-FFR-CZT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital

Grenoble, France

Location

Related Publications (1)

• 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.

  PMID: 25381092 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gilles GB Barone-Rochette, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 7, 2013
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

FR (1)