Validation of Myocardial Perfusion Imaging (CameraCZT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01785589
First received: January 29, 2013
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: coronary angiography
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography

Further study details as provided by University Hospital, Grenoble:

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 [ 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.



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 [ 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.



Estimated Enrollment: 220
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:
  • 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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785589

Contacts
Contact: BARONE ROCHETTE MD Gilles (33+)476768440 GBarone@chu-grenoble.fr

Locations
France
University Hospital Recruiting
Grenoble, France
Contact: BARONE ROCHETTE MD Gilles    (33+)476768480    GBarone@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Gilles GB Barone-Rochette, MD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01785589     History of Changes
Other Study ID Numbers: IRB 5891
Study First Received: January 29, 2013
Last Updated: February 11, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
coronary artery disease
cardiac nuclear medicine
myocardial perfusion imaging
invasive coronary angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014