Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve

Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: SPECT Imaging with 99mTc-Tetrofosmin Research Imaging

Detailed Description

Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitaire Ziekenhuizen Leuven
• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
• Germany
  • Hannover, Germany
    • Medizinische Hochschule Hannover
• Italy
  • Brescia, Italy
    • Nuclear Medicine, Università & Spedali Civili, Brescia, Italy
• Japan
  • Toon, Japan
    • Ehime University Hospital
• Singapore
  • Singapore, Singapore, 169609
    • National Heart Center Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the local site, have known or suspected CAD and are deemed to clincally require MBF measurements.

Description

Inclusion Criteria:

• Age ≥ 18 years old
• BMI ≤ 40 kg/m2
• Able and willing to comply with the study procedures
• Written informed consent
• Intermediate to high probability of CAD
• Suspected or known CAD on a stable medication regime

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 within 45 days after consent (early revascularization)
• Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization)
• Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
• Known hypersensitivity to dipyridamole or adenosine
• Breastfeeding or pregnancy
• Claustrophobia or inability to lie still in a supine position
• Unwillingness or inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SPECT Imaging with 99mTc-Tetrofosmin; Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin

Diagnostic test: SPECT Imaging with 99mTc-Tetrofosmin Research Imaging; This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation in MBF Between Core Laboratory and Local Site	MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.	The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Throughput	Additional acquisition time for the MBF acquisition. For each patient study, the time during which the patient was in the camera room for each imaging session was recorded along with the start times for each scan. From this data, the increase in time for MBF protocol compared with the time for a standard myocardial perfusion imaging protocol was determined.	The average total time the patient was in the camera room during the study protocol was 72.28 minutes.

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: SPECT; Myocardial Blood Flow
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium tc-99m tetrofosmin
• Other Study ID Numbers: 20170797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No