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Completed

NCT Number: NCT03427749

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire ziekenhuizen Leuven, Leuven, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Correlation in MBF Between Core Laboratory and Local Site

    Time frame: 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 outcomes

  1. Impact on Throughput

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2018
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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