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.