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Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF) (SPECT MBF)

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ClinicalTrials.gov Identifier: NCT02280941
Recruitment Status : Recruiting
First Posted : November 3, 2014
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation

Brief Summary:
This study is being done to compare the blood flow measurements obtained with the SPECT and PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise information in diagnosing heart problems. SPECT scans, with new camera technology and computer software, now have the potential to also give this additional information. The study is investigating how well the blood flow measurements from SPECT compared to PET.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Other: single photon emission computed tomography Not Applicable

Detailed Description:

Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) are calculated measurements that are obtained using positron emission tomography (PET) nuclear imaging, from a myocardial perfusion imaging (MPI) stress test, due to the advanced capabilities of the PET camera technology. These calculations provide more diagnostic and prognostic information for patients. Single photon emission computed tomography (SPECT) nuclear imaging is more widely done due to the availability and lower costs, but in the past has not been able to provide the additional information needed to perform the MBF and MFR calculations. SPECT cameras have now been developed and are in use, as well as software for the cameras that have shown that these measurements can be obtained from SPECT. The goal of this study is to compare SPECT and PET measurement of MBF and MFR and determine the reproducibility of SPECT MFR measurements.

The study will be done in 3 Phases, with recruitment done over 3 years. Phase 1 and 2 will be done over the first 2 years, with Phase 3 planned following Phases 1 and 2, in the 3rd year of recruitment.

Phase 1: patients with coronary artery disease, who are coming to the University of Ottawa Heart Institute (UOHI) for MPI stress testing will have both a PET and SPECT MPI for comparison of the measurements of MBF and MFR. The PET scan will be done as the clinical, reportable test.

Phase 2: patients with coronary artery disease, who are coming to UOHI for SPECT MPI testing will have the SPECT repeated to see how reproducible the measurements are.

Phase 3: normal, healthy volunteers will have both a PET and SPECT scan for the comparison of the measurements of MBF and MFR.

No change to any patient care will be done in Phases 1 and 2. Phase 1 and Phase 2 participants will have 1 research scan and Phase 3 participants will have 2 research scans.

Rubidium (Rb-82) Elution System Performance Data will be collected on the elution pump system, used to deliver the Rb-82 isotope, to support the system performance documentation for Health Canada Authorization.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82
Actual Study Start Date : October 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cadmium

Arm Intervention/treatment
Experimental: Single photon emission computed tomography
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
Other: single photon emission computed tomography
Single photon emission computed tomography (SPECT) imaging will be done.




Primary Outcome Measures :
  1. Correlation [ Time Frame: 3 years ]
    The correlation of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) and 99mTc-tetrofosmin (99mTc) to positron emission tomography (PET) and Rubidium-82 (Rb-82) will be determined.

  2. Reproducibility [ Time Frame: 3 years ]
    The reproducibility of global and regional myocardial blood flow (MBF) measurements and calculated myocardial flow reserve (MFR) using single photon emission computed tomography (SPECT) will be determined.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all participants

  • Age ≥ 18 years old
  • BMI ≤ 40 kg/m2
  • Able and willing to comply with the study procedures
  • Written informed consent Participants with intermediate to high probability of CAD
  • Suspected or known CAD on a stable medication regime. Healthy volunteers without known heart disease
  • Low risk of CAD (ACC Guidelines Pre-test Probability of Coronary Disease by Symptoms, Gender and Age)

Exclusion Criteria:

  • History or risk of severe bradycardia (heart rate < 50 beats per minute) not related to chronotropic drugs
  • Known second- or third-degree AV block without pacemaker
  • Dyspnea (NYHA III/IV), wheezing asthma or COPD
  • Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or at any time after consent
  • Percutaneous coronary intervention (PCI) within 30 days prior to screening or at any time following consent
  • Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent
  • Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
  • Known hypersensitivity to dipyridamole
  • Breastfeeding or pregnancy
  • Claustrophobia or inability to lie still in a supine position
  • Unwillingness or inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280941


Contacts
Contact: Clare Carey, BScN 613-696-7000 ext 15103 CCarey@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Clare Carey, BScN    613-696-7000 ext 15103    CCarey@ottawaheart.ca   
Principal Investigator: Terrence Ruddy, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
GE Healthcare
Investigators
Principal Investigator: Terrence Ruddy, MD Ottawa Heart Institute Research Corporation

Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02280941     History of Changes
Other Study ID Numbers: 20140589
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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