Washington University School of Medicine (WUSM)/American College of Radiology (ACR) Positron Emission Tomography (PET) Core Laboratory
The WUSM-ACR PET Core Laboratory is under the direction of Robert J. Gropler, MD (WUSM) and Paul E. Kinahan, PhD (ACR). This partnership between the
WUSM Imaging Core Laboratory (WUSM-ICL) and the ACR Imaging Core Laboratory (ACR-ICL) will serve to bring cutting-edge qualification, quality control,
and analytics to PET imaging conducted in CCTRN research.
Dr. Gropler will have primary oversight responsibilities for all CCTRN PET Core Lab activities. He serves as the chief of both the
Division of Radiological Sciences and the Cardiovascular Imaging Laboratory at the Mallinckrodt Institute of Radiology (MIR). For 25+ years
he and his group have used PET and other advanced imaging tools to study the myocardial metabolic-functional relation, in both preclinical
and clinical studies, in a host of normal and abnormal cardiac states. The WUSM-ICL has extensive experience as a cardiac PET core laboratory
providing services for 55 single-center or multicenter trials. Dr. Kinahan and the ACR-ICL team will act as the infrastructure and communications
hub for the CCTRN’s WUSM/ACR PET Core Laboratory. The ACR-ICL provides extensive expertise in site qualification, data transfer, quality assurance
(QA), quality control (QC), communication, data management, and storage retention. The ACR-ICL will coordinate communications among participating
sites, the WUSM-ICL, the CCRTN DCC, and study development teams. Dr. Kinahan, also
a Professor of Radiology at the University of Washington in Seattle, will have primary oversight responsibilities for all ACR-ICL activities.
To learn more about the WUSM-ICL, please visit the WUSM Cardiovascular Imaging and Clinical Research Core Laboratory website. To learn more about the
ACR-ICL, please visit the ACR-ICL PET Core Laboratory website.
Duke Clinical Research Institute (DCRI) Imaging Program CCTRN Echocardiography Core Laboratory
The DCRI Imaging Program, which includes a multimodality core laboratory, is under the direction of Pamela S. Douglas,
MD, MACC, FAHA, FASE, FAHA, Geller Professor of Research in Cardiovascular Diseases at Duke University. Dr. Douglas has
more than 30 years of experience in cardiovascular and imaging research, including leading the development of nationally
adopted echocardiography core lab best practice standards
(J Am Soc Echocardiogr. 2009; 22:755-66).
The Imaging Program at DCRI is one of the most respected imaging clinical trial groups in the world with over 30 years
experience in providing high quality conventional echocardiographic measurements, including chamber and great vessel size
and volume by M-mode, single, biplane and multi-plane (3D) assessments, right and left ventricular systolic and diastolic
function, pulsed-wave, continuous and color flow Doppler of all valves and cardiac pump cannulae, tissue Doppler of myocardial
velocities, and systolic and diastolic intervals. Additionally, DCRI’s Imaging Program has expertise performing advanced
echocardiographic measurements in the core lab setting, including multi-vendor LV and RV strain and strain rate, 3D, trans-esophageal
echo, and quantitation of mitral regurgitation.
DCRI has provided high quality imaging acquisition oversight and analyses for over 25 preclinical and Phase I - IV clinical trials,
encompassing nearly 9000 subjects and 50,000 echoes. Of especial relevance to the CCTRN, these numbers include four stem cell studies,
four VAD studies, and six other heart failure studies, which total 2,829 subjects and 13,049 echoes.
To learn more about DCRI’s Imaging Program, go to website.
Massachusetts General Hospital (MGH) Cardiopulmonary Exercise Testing (CPET) Core Laboratory
The MGH CPET Core Laboratory is under the direction of Gregory Lewis, MD.
Dr. Lewis and his team have over 80 years of collective experience in CPET
performance and interpretation at MGH. The CPET Core Lab performs over 700
clinical and research CPETs per year, many of which are coupled with invasive
hemodynamic monitoring, echocardiography and radionuclide ventriculography.
The MGH CPET Lab is a national referral center for detailed physiologic evaluations
of heart failure and other cardiopulmonary conditions in which precise physiologic
measurements are required.
MGH has served as the CPET core lab for multiple trials and is currently also the
core lab for the NHLBI Heart Failure Network (HFN), the NHLBI-sponsored Hypertrophic
Cardiomyopathy Network (HCM♥NET) upcoming VANISH Trial, as well as several
industry-sponsored studies. The core lab’s approach has been informed by direct
experience in caring for patients with cardiovascular diseases and designing trials
in heart failure. The core lab offers innovative approaches to remote CPET equipment
calibration and certification, methods to achieve uniformity in gas-exchange analysis
and harmonization of cycle ergometry and treadmill testing, and approaches to confront
challenges associated with interpretation of exercise gas exchange data in heart failure
To learn more about the CPET, please visit the MGH CPET Core Lab
The Biorepository Core (BRC) Lab at Texas Heart Institute
The BRC is under the co-direction of Doris A. Taylor, PhD, FAHA, FACC and Adrian
P. Gee, PhD, MI Biol, who have more than 20 years’ experience in the field. Dr.
Taylor, an innovator in regenerative medicine, brings specific experience-related
insight into the requirements for cell therapy, cell profiling, and biospecimen
storage. Recognized for his work in cellular therapy, Dr. Gee oversees all quality
assurance (QA) aspects of the BRC at THI. Drs. Taylor and Gee lead a team of scientists
and coordinators with expertise in flow cytometry, cell function analyses, and biochemical
assays who conduct the phenotyping and functional analyses.
The overall purpose of a Biorepository Core is to support the mission of the Cardiovascular
Cell Therapy Research Network (CCTRN) by storing biologic specimens from patients
enrolled in cell therapy trials and by conducting analyses to help advance the safe,
efficacious use of cell therapy in treating cardiovascular diseases. The BRC is
a 2000-square foot, state-of-the-art biosafety level (BSL)-2 facility that can provide
biospecimen storage, processing, and testing on a fee-for-service basis to support
the CCTRN. These services will enable the CCTRN to characterize cells used in therapeutic
applications and the patient response to those cells as dictated by protocol.
To learn more about the BRC, please visit the Texas Heart Institute BRC
The Magnetic Resonance Imaging (MRI) Core Lab at Johns Hopkins University
The MRI Core lab is under the direction of Joao Lima, MD. Dr. Lima is widely credited
as one of the pioneers in the field, developing mainstay methods by which myocardial
infarct tissue is visualized and measured using the modality. His developmental
role in the field has led to him spearheading the largest population studies done
to date using MR studies: the Epidemiology of Diabetes Interventions and Complications
Study (EDIC) and the Multi-Ethnic Study of Atherosclerosis (MESA) Study.
In addition to EDIC and MESA, the MRI Core Lab at Johns Hopkins University has conducted
the analysis for the recently published SCIPIO trial and currently serves as the
Core lab for the ALLSTAR stem cell clinical trial. The MRI Core has an experienced
team of physicists, imaging technologists, and quality control experts to oversee
MR studies with emphasis in both cardiac and vascular realms.
To learn more about the MRI Core lab at Johns Hopkins University, please email Erin Ricketts, Research Program Manager.
The CPC Clinical Research affiliated with the University of Colorado School of Medicine
Many studies that employ symptomatic or functional endpoints experience problems
with endpoint variability and excessive placebo response. Each of these issues results
in inconclusive data that make it difficult or impossible to interpret the effectiveness
of an intervention. The CPC team has pioneered a program coined the Endpoint Quality
Intervention Program (EQuIP) to effectively minimize the variability that has historically
plagued multicenter cardiovascular studies with functional or symptomatic endpoints.
EQuIP has decreased the variance of the treadmill endpoint in several drug, gene
and cell-based studies. Aimed at ensuring data integrity throughout a clinical study,
this program works throughout the life of the trial to ensure that the right endpoints
are chosen and appropriately described and collected in the study documents, that
effective training tools are available, (e.g. on-line training videos, procedure
reference tools, electronic endpoint criteria calculators), and stresses the importance
of hands-on training at the sites to improve the likelihood of trial success.
The CPC is under the direction of William Hiatt, MD. Dr. Hiatt’s academic career
has focused on the clinical, educational, and research issues in peripheral artery
disease (PAD). He has contributed to over 63 PAD clinical investigations. To learn
more about the CPC, please visit the CPC website.