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Coronary Artery Disease (CAD)Phase 3NCT03354273

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

A Phase 3 study testing PET MPI, SPECT MPI and Pharmacological stress agents in people with Coronary Artery Disease (CAD), run by GE Healthcare at 53 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
PET MPI, SPECT MPI and Pharmacological stress agents
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
730 participants
Where
53 sitesin 7 countries
Study dates
5 Jun 2018to 5 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

53 sites in 7 countries.

53 sites in 7 countries

United States37 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Vascular Biology and Hypertension Program, University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • VA North Texas Health Care System - NAVREF - PPDS

    Dallas, Texas, 75216

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • University of Florida

    Gainesville, Florida, 32610

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Vital Heart & Vein

    Humble, Texas, 77338

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Memorial City and Katy Cardiology Associates

    Katy, Texas, 77493

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of California- Los Angeles

    Los Angeles, California, 90024

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • VA Greater Los Angeles Health Care System

    Los Angeles, California, 90073

  • Optimus U Corp

    Miami, Florida, 33125

  • Infinite Clinical Research

    Miami, Florida, 33133-4214

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Comprehensive Vascular Care PA

    Miami, Florida, 33155

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building

    New York, New York, 10032

  • Cardiology Physicians PA/Red Clay Research LLC

    Newark, Delaware, 19713

  • Amavita Clinical Research, LLC

    North Miami Beach, Florida, 33169

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Roanoke Heart Institute

    Roanoke, Virginia, 24014

  • VA San Diego Health System

    San Diego, California, 92161

  • UCSF

    San Francisco, California, 94107

  • Tower Saint John's Imaging

    Santa Monica, California, 90403

  • VA St. Louis Health Care System

    St Louis, Missouri, 63106

  • St Louis University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Berks Cardiologists, LTD

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Netherlands5 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis - WCN - PPDS

    Breda, 4818 CK

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Zuyderland Medisch Centrum-WCN-PPDS

    Heerlen, 6419 PC

  • Leids Universitair Medisch Centrum

    Leiden, 2333ZA

Other trials in Netherlands

Canada3 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Center Hospitalier Universitaire de Sherbrooke CHUS

    Montreal, Quebec, J1H 5N4

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

France3 sites

  • Hopital Cote de Nacre

    Caen, 14033

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018

  • Centre Cardiologique Du Nord

    Saint-Denis, 93200

Other trials in France

Germany2 sites

  • Universitätsklinikum der RWTH Aachen

    Aachen, 52074

  • Universitätsklinikum Essen

    Essen, 45147

Other trials in Germany

Switzerland2 sites

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Finland1 site

  • Turku University Hospital

    Turku, FI-20520

Other trials in Finland

About this study

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

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.

Being tested
PET MPI, SPECT MPI, Pharmacological stress agents
Keywords
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 (CAD)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET MPIDrug

    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.

  • SPECT MPIDrug

    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.

  • Pharmacological stress agentsDrug

    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.

Study groups in NCT03354273
Study groupRoleWhat they receive
1ExperimentalFlurpiridaz PET MPI (following off-study SPECT MPI)
Receives: Drug: PET MPI; Drug: SPECT MPI; Drug: Pharmacological stress agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization

    Sensitivity was defined as true positives (TP)/(TP+false negatives [FN]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives [FP]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50 percent (%) in >=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers.

    Measured: Up to 60 days

Secondary outcomes (4)

  1. Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth

    Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity was calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for all participants was reported by reader and majority rule.

    Measured: Up to 60 days

  2. Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth

    Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of a coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for female participants was reported by reader and majority rule.

    Measured: Up to 60 days

  3. Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth

    Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for participants(BMI>=30 kg/m^2) reported by reader and majority rule.

    Measured: Up to 60 days

  4. Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth

    Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for diabetic participants was reported by reader and majority rule.

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start5 Jun 2018
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354273
Sponsor's protocol ID
GE-265-303
Other IDs
2017-005011-14, 2017
Status last verified
Jun 2023
First submitted
21 Nov 2017
Last updated
12 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Patel KK, Maddahi J, Agostini D, Bax JJ, Beanlands RSB, Berman D, Dorbala S, Heller GV, Knuuti JM, Pelletier-Galarneau M, Tamaki N, Thompson D, Somer EJ, Udelson JE, Bateman TM. Improved assessment of coronary artery disease in obese patients with flurpiridaz-18F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study. J Nucl Cardiol. 2026 Jul;61:102741. doi: 10.1016/j.nuclcard.2026.102741. Epub 2026 May 12.

    PubMed 42128226

  • Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016.

    PubMed 37821170

  • Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.

    PubMed 33521873

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PET MPI, SPECT MPI and Pharmacological stress agents in people with Coronary Artery Disease (CAD), run by GE Healthcare at 53 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Netherlands, Canada, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03354273, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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