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: Recruiting
• Conditions: Coronary Artery Disease

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 (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Clare Carey, BScN; Phone Number: 15103 613-696-7000; Email: CCarey@ottawaheart.ca
• Study Contact Backup: Name: Terrence Ruddy, MD; Phone Number: 613-696-7312; Email: truddy@ottawaheart.ca

Study Locations

• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • Universitaire Ziekenhuizen Leuven
    • Contact: Oliver Gheysens, MD
• Canada
  • Ontario
    • London, Ontario, Canada
      • Active, not recruiting
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Terrence Ruddy, MD; Phone Number: 6136967312; Email: truddy@ottawaheart.ca
      • Contact: Clare Carey, Ontario; Phone Number: 15103 6136967000; Email: ccarey@ottawaheart.ca
• Germany
  • Hannover, Germany
    • Not yet recruiting
    • Medizinische Hochschule Hannover
    • Contact: Frank Bengel, MD
• Japan
  • Toon, Japan
    • Not yet recruiting
    • Ehime University Hospital
    • Contact: Masao Miyagawa, MD, PhD
• Singapore
  • Singapore, Singapore, 169609
    • Not yet recruiting
    • National Heart Center Singapore
    • Contact: Keng Yung Jih Felix, MBBS, MRCH, MMed

Participation Criteria

Eligibility Criteria

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

• 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	It is practical to obtain reliable SPECT measurements of MBF routinely within the workflow of a standard clinical practice	2 years
MBF reproducibility	Global MBF measured at remote sites will agree within 10% with the same data processed at an expert core laboratory.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on throughput	Routine implementation of a SPECT MBF protocol will have at most minimal impact on patient throughput (defined as <10% reduction in patient volumes).	2 Years
Delayed imaging	Static reconstruction of the last 6 min of the dynamic acquisition will provide images that are clinically equivalent (less than 10% change in patient diagnosis from normal (summed stress score < 4) to abnormal or vice versa), compared to standard static images obtained following a 45-min delay post-injection	2 years
Half-dose MBF measurement	The difference between MBF measurements with full-data and half-data dynamic acquisitions will be less than or equal to the inter-observer variation in MBF measurements with full-data	2 years

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 (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 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): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: SPECT; Myocardial Blood Flow
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• 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