Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jose Hernandez Pampaloni

Description

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.

Official Title

A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

Keywords

Coronary Artery Disease (CAD) Positron emission tomography myocardial perfusion imaging (PET MPI) Single photon emission computed tomography myocardial perfusion imaging (SPECT MPI) Invasive coronary angiography (ICA) Coronary Artery Disease Myocardial Ischemia Coronary Disease PET MPI SPECT MPI Pharmacological stress agents

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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:
  • Previous myocardial infarction (MI);
  • Previous cardiac catheter angiography showing ≥50% stenosis;
  • 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.

Locations

  • UCSF accepting new patients
    San Francisco California 94107 United States
  • University of California- Los Angeles accepting new patients
    Los Angeles California 90024 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GE Healthcare
ID
NCT03354273
Phase
Phase 3
Study Type
Interventional
Last Updated