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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427749
• Other study ID #: 20170797
• Status: Recruiting
• Start date: October 12, 2018
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Ottawa Heart Institute Research Corporation
• Contact: Clare Carey, BScN
• Phone: 613-696-7000
• Email: ccarey[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Belgium	Universitaire ziekenhuizen Leuven	Leuven
Canada	London Health Sciences Centre	London	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Germany	Medizinische Hochschule Hannover	Hannover
Japan	Ehime University Hospital	Toon
Singapore	National Heart Center Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	GE Healthcare

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Japan,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	It is practical to obtain reliable SPECT measurements of MBF routinely within the workflow of a standard clinical practice	2 years
Primary	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	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
Secondary	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
Secondary	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