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

Completed

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).

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Correlation in MBF Between Core Laboratory and Local Site	The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Impact on Throughput	The average total time the patient was in the camera room during the study protocol was 72.28 minutes.	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.

Locations (7): Nuclear Medicine, Università & Spedali Civili, Brescia, Italy
🇮🇹
Brescia, Italy
Universitaire ziekenhuizen Leuven
🇧🇪
Leuven, Belgium
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦
Ottawa, Ontario, Canada
Medizinische Hochschule Hannover
🇩🇪
Hannover, Germany
Ehime University Hospital
🇯🇵
Toon, Japan
National Heart Center Singapore
🇸🇬
Singapore, Singapore