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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:June 8, 2018
End Date:August 2020
Contact:Aleksandar Sarac
Email:aleksandar.sarac@ge.com
Phone:+44 (0) 1494 546 138

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
23
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Katy, TX
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90073
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Morgantown, West Virginia
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
915 North Grand Boulevard
Saint Louis, Missouri 63106
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Tomball, TX
Click here to add this to my saved trials
?
mi
from
Turku,
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials