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

NCT03427749 | Completed Results

• 1 other identifier: 20170797
• Study Type: observational
• Target: 35
• Locations: 6 countries
• Sites: 7

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.

Conditions

Coronary Artery Disease

Keywords

Myocardial Blood Flow; SPECT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact on Throughput

  The average total time the patient was in the camera room during the study protocol was 72.28 minutes.

Study Arms (1)

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

Interventions

SPECT Imaging with 99mTc-Tetrofosmin Research Imaging 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.

SPECT Imaging with 99mTc-Tetrofosmin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

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 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

Sponsors & Collaborators

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

Study Sites (7)

Universitaire ziekenhuizen Leuven

Leuven, Belgium

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Nuclear Medicine, Università & Spedali Civili, Brescia, Italy

Brescia, Italy

Location

Ehime University Hospital

Tōon, Japan

Location

National Heart Center Singapore

Singapore, 169609, Singapore

Location

Related Publications (1)

• 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.

  PMID: 37800325 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

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

truddy@ottawaheart.ca

613-696-7267

Study Officials

• Terrence Ruddy, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: October 12, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); BE (1); JP (1); SG (1); CA (2); IT (1)