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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating. - Participants who were unable to undergo all of the imaging procedures. - Participants who had 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. - Participants incapable of undergoing either exercise or pharmacological cardiac stress testing. - Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing. - Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%). - Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA. - Participants undergoing evaluation for heart transplantation or with history of heart transplantation. - Participants 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
1 		Flurpiridaz PET MPI (following off-study SPECT MPI)
  • Drug: PET MPI
    Flurpiridaz (18F) Injection. All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions did not exceed a total of 14 mCi (520 MBq) for an individual participant.
  • Drug: SPECT MPI
    SPECT imaging was used 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study was administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All participants undergone SPECT MPI.
  • Drug: Pharmacological stress agents
    Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration was through an IV line.

More Details

Status
Completed
Sponsor
GE Healthcare

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.