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Phase III

An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

  • Study HIC#:2000023850
  • Last Updated:07/15/2021

Brief Summary:

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

  • Age18 years and older
  • GenderBoth
  • Start Date01/30/2019
  • End Date08/31/2020

Trial Purpose and Description

Assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (18F) Injection PET myocardial perfusion imaging (MPI) in the detection of significant CAD, as defined by invasive coronary angiography (ICA), in patients with suspected CAD.

Eligibility Criteria

Inclusion Criteria: 

The subject is a man or woman & 18 years of age.
The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
The subject has undergone a clinically indicated SPECT OR the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:
Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
Patients who are unable to undergo all of the imaging procedures.

Patients who have an established diagnosis of CAD as confirmed by any of the following:
1.Previous myocardial infarction (MI);
2.Previous cardiac catheter angiography showing & 50% stenosis;
3.Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.

Patients incapable of undergoing either exercise or pharmacological cardiac stress testing.
Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) &50%).
Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study. 

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