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

NCT02280941 | Completed Results

• 1 other identifier: 20140589
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT

  PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET.

  From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.

• Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans

  SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans.

  From enrollment to completion of imaging was a maximum of four weeks.

Study Arms (1)

Single photon emission computed tomography

EXPERIMENTAL

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

Interventions

single photon emission computed tomography OTHER

Single photon emission computed tomography (SPECT) imaging will be done.

Single photon emission computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (3)

• Wells RG, Marvin B, Poirier M, Renaud J, deKemp RA, Ruddy TD. Optimization of SPECT Measurement of Myocardial Blood Flow with Corrections for Attenuation, Motion, and Blood Binding Compared with PET. J Nucl Med. 2017 Dec;58(12):2013-2019. doi: 10.2967/jnumed.117.191049. Epub 2017 Jun 13.

  PMID: 28611245 RESULT

• Do J, Ruddy TD, Wells RG. Reduced acquisition times for measurement of myocardial blood flow with 99mTc-tetrofosmin and solid-state detector SPECT. J Nucl Cardiol. 2021 Dec;28(6):2518-2529. doi: 10.1007/s12350-020-02048-w. Epub 2020 Feb 5.

  PMID: 32026329 RESULT

• Wells RG, Radonjic I, Clackdoyle D, Do J, Marvin B, Carey C, deKemp RA, Ruddy TD. Test-Retest Precision of Myocardial Blood Flow Measurements With 99mTc-Tetrofosmin and Solid-State Detector Single Photon Emission Computed Tomography. Circ Cardiovasc Imaging. 2020 Feb;13(2):e009769. doi: 10.1161/CIRCIMAGING.119.009769. Epub 2020 Feb 11.

  PMID: 32069116 RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Terrence Ruddy
• Organization: University of Ottawa Heart Institute

truddy@ottawaheart.ca

6136967000

Study Officials

• Terrence Ruddy, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: November 3, 2014
• Study Start: October 30, 2014
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)