Clinical trial NCT03427749: Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Official title: Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Myocardial Blood Flow
SPECT
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2018-02-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Correlation in MBF Between Core Laboratory and Local Site
timeFrame: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
Secondary outcomes:
measure: Impact on Throughput
timeFrame: The average total time the patient was in the camera room during the study protocol was 72.28 minutes.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire ziekenhuizen Leuven
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Brescia
country: Italy
facility: Nuclear Medicine, Università & Spedali Civili, Brescia, Italy
city: Toon
country: Japan
facility: Ehime University Hospital
city: Singapore
country: Singapore
facility: National Heart Center Singapore
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Terrence Ruddy, MD
role: PRINCIPAL_INVESTIGATOR
References: