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

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ClinicalTrials.gov Identifier: NCT03354273
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Pharmaceutical Product Development, LLC
Information provided by (Responsible Party):
GE Healthcare

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Drug: PET MPI Drug: SPECT MPI Drug: Pharmacological stress agents Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Flurpiridaz PET MPI (following off-study SPECT MPI)
Drug: PET MPI
Flurpiridaz (18F) Injection. All subjects will receive 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 will not exceed a total of 14 mCi (520 MBq) for an individual subject.

Drug: SPECT MPI
SPECT imaging must use 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study will be administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All patients will undergo SPECT MPI.

Drug: Pharmacological stress agents
Pharmacologic stress agents will be restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration will be through an IV line.




Primary Outcome Measures :
  1. Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI in the detection of significant CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in patients with suspected CAD


Secondary Outcome Measures :
  1. Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]

    Defined by invasive coronary angiography, in female subjects

    • All subjects (key secondary endpoint)
    • Female subjects
    • Subjects with body mass index (BMI) ≥30 kg/m2
    • Diabetic subjects

  2. Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in subjects with body mass index (BMI) ≥30 kg/m2

  3. Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in diabetic subjects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354273


Contacts
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Contact: Aleksandar Sarac +44 (0) 1494 546 138 aleksandar.sarac@ge.com
Contact: Corina Harper (774) 249- 6014 Corina.Harper@ge.com

  Show 23 Study Locations
Sponsors and Collaborators
GE Healthcare
Pharmaceutical Product Development, LLC
Investigators
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Study Director: Francois Tranquart, M.D., Ph.D. General Electric Healthcare Life Sciences

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03354273     History of Changes
Other Study ID Numbers: GE-265-303
2017-005011-14 ( EudraCT Number )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases