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

NCT ID: NCT03427749

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-12
• Study Completion Date: 2022-10-01

Brief Summary

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.

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).

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

SPECT Imaging with 99mTc-Tetrofosmin Research Imaging

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terrence Ruddy, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

Universitaire ziekenhuizen Leuven

Leuven, , Belgium

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Medizinische Hochschule Hannover

Hanover, , Germany

Nuclear Medicine, Università & Spedali Civili, Brescia, Italy

Brescia, , Italy

Ehime University Hospital

Tōon, , Japan

National Heart Center Singapore

Singapore, , Singapore

Countries

Belgium; Canada; Germany; Italy; Japan; Singapore

References

Wells RG, Bengel FM, Camoni L, Cerudelli E, Cuddy-Walsh SG, Diekmann J, Han L, Kadoya Y, Kawaguchi N, Keng YJF, Miyagawa M, Ratner H, Teng XF, Ruddy TD. Multicenter Evaluation of the Feasibility of Clinical Implementation of SPECT Myocardial Blood Flow Measurement: Intersite Variability and Imaging Time. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015009. doi: 10.1161/CIRCIMAGING.122.015009. Epub 2023 Oct 6.

Reference Type: DERIVED

PMID: 37800325 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20170797

Identifier Type: -

Identifier Source: org_study_id