Our experience extends across FIH, EFS, pivotal, post-marketing surveillance and IDE trials
Cardiac imaging core lab (CICL) offers independent third-party analysis and interpretation of echocardiographic images for industry-sponsored and investigator-led clinical trials
CICL offers the following modalities:
- 2D and Doppler echocardiography
- 3D structural and functional analyses of the mitral valve, tricuspid valve, left ventricle and right ventricle
- Speckle tracking strain
Servicios
Quality image analysis
- Two-step verification: All images analyzed by our sonographers are verified and finalized by a qualified physician.
- Rigorous quality check of data-entry: All data entered into the EDC is checked by a second CICL staff member to ensure they match with that entered into the PACS system and are error-free.
- Control for inter/intra-operator variability: We periodically assess measurements by our sonographers, and retrain them if necessary, to mitigate variability in measurements that impact study data.
- Turnaround time: Complete analysis of screening cases in 24-36 hours, and follow-up images in 72 hours, on average.
- Capacity: Standard support analysis of several thousand images per year with ability to expand staff as needed.
- Compliance with industry regulations: FDA Regulations, FDA Guidance for Industry (Computerized systems and Electronic Source Data in Clinical Investigations) and ICH-GCP E6, ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects).
Study documentation development
- Development of a reference Echo manual and study documentation, including illustrations, protocol, CRFs, and SOPs per project needs and appropriate GCP, ICH and FDA regulations.
Site training
- Creation of training materials and execution of a web-based training for site cardiographers to ensure standardized acquisition of images across sites for the trial.
Image transfer and storage
- Sites will transfer study images via an Image Management System (IMS) selected by Sponsor, or via digital media and national courier. The Core Lab will only accept de-identified studies that do not contain protected health information (PHI).
- All images and data are stored on a secured network drive that is mirrored nightly. Records will be retained in accordance with the sponsor’s required duration. Data is accessible only to the authorized Core lab personnel.
PERICIA
Medical Director Paul Grayburn, MD brings more than 40 years of echocardiography experience in the valvular heart disease to the Core Lab. The program's world-renowned team of cardiac sonographers embody years of extensive experience in the structural and valvular heart disease field, with several high-impact scientific publications.
The program’s effective team of cardiac sonographers embody years of extensive experience in the structural and valvular heart disease field, with several high-impact scientific publications.
Areas of expertise
- Mitral Regurgitation: Percutaneous and surgical treatment strategies
- Tricuspid Regurgitation: Percutaneous and surgical treatment strategies
- Aortic Stenosis: Percutaneous and surgical treatment strategies
- Heart Failure: Medical and Device Treatment
- Aortic Disease: Acute Dissection
Clinical breadth and depth of our sonographers
- Our cohesive group of experienced sonographers have extensive echocardiography practice and undergo formal training to standardize techniques of image analysis.
- CICL Sonographers are long-term members of professional societies such as American Society of Echocardiography (ASE) and American Society of Radiologic Technology (ASRT). They are also trained on human subjects research practices such as GCP, HSP and handling of electronic data.
Assured consistent quality
We take special measures to remove bias and variability due to subjective interpretation of images by our sonographers.
Time-zone coverage
Our team is distributed in the US, Germany and Italy, allowing us to provide round-the-clock support to our study-sponsors.
Track record
We are actively engaged in several large-scale trials at the highest standards of service.
Leadership and staff
Liderazgo
As part of Baylor Scott & White The Heart Hospital – Plano, our Core Lab is guided by an expert senior leadership team of world-renowned cardiac surgeons and cardiologists with extensive expertise in directing image-related research studies and leading numerous national and international trials.
Scientific leadership
Paul A. Grayburn, MD, FACC, FASE
Medical Director
Paul A. Grayburn is the Director of Cardiology Research at Baylor Scott and White Research Institute, and Director of Noninvasive Cardiology at The Heart Hospital Baylor Plano. He received his M.D. from the University of Texas Medical Branch in 1981. After an internship and residency training in Internal Medicine at St. Paul Medical Center/UT Southwestern in Dallas, Dr. Grayburn completed his Cardiology and Interventional Cardiology training at the University of Kentucky Medical Center under the mentorship of Dr. Anthony DeMaria. He, then, served as Chief of Cardiology at the Veterans Affairs Medical Center and as the Director of the Echocardiography Laboratories for UT Southwestern Medical Center where he advanced to Professor of Medicine. In septiembre 2002, Dr. Grayburn accepted the Paul Thomas Endowed Chair in Cardiology at Baylor University Medical Center at Dallas. Dr. Grayburn has coauthored more than 400 articles in medical journals and 10 book chapters. He has participated in several multicenter trials that have changed our understanding and management of cardiovascular diseases. He is an expert in echocardiography and valvular heart diseases, a member of the editorial boards of multiple major scientific journals and currently an Associate Editor of JACC: Cardiovascular Imaging, American Journal of Cardiology and Structural Heart Disease. Dr. Grayburn has been awarded the National Institutes of Health R01 and K24 Awards. The K24 grant is awarded for stellar track record of mentoring junior faculty members. Several of his former trainees now hold faculty positions at several institutions, including UCSF, Johns Hopkins, Vanderbilt, UT Southwestern and Mid-America Heart Institute.
Anna Sannino, MD, PhD, FASE
Scientific Director
Anna graduated in Medicine from the University Federico II of Naples, Italy in 2009. During her MD school years, Anna started her research pathway with an internship in the Cardiology Department of the University Federico II, under the mentorship of Prof. Giovanni Esposito and Prof. Massimo Chiariello. There, she spent the last 2 years of her MD course, working on basic research topics, focusing on uncoupling proteins and their role on cardiac remodeling after myocardial infarction. This basic background has been invaluable for her subsequent growth both as a researcher and as a physician. After MD school, Anna successfully applied to the Cardiovascular Medicine Residency Program of the same University. During her residency years, Anna’s research interests shifted from basic to clinical cardiovascular issues. Anna was indeed fascinated by the capability of non-invasive diagnostic tools, imaging modalities such as ultrasound, CT and magnetic resonance, to detect cardiovascular disease with exceptional accuracy. Anna started working on aortic stenosis form either a pathophysiologic and clinical standpoint. Her passion for valvular heart disease has grown exponentially since then, and by the time she completed her residency program in Cardiovascular Medicine, Anna had already published a few papers on these topics. In 2015, Anna started her PhD and moved to Dallas to work with Paul A. Grayburn at the Baylor Scott & White Research Institute, Department of Cardiology. Under his mentorship, Anna expanded her knowledge on the patho-physiology of valvular heart disease, with a particular focus on mitral and tricuspid regurgitation. Her years in the US have represented a career lunch for Anna. She has been involved in the Cardiac Imaging Core Lab since the early 2019 and soon appointed as Scientific Director in enero 2020. In the meantime, Anna has also been pursuing her academic career and is now an Assistant Professor in the Department of Cardiology of the University Federico II of Naples, Italy. Anna is a Fellow of the American Society of Echocardiography and a Nucleus Member of the Council on Valvular Heart Disease of the European Society of Cardiology. She is an active reviewer for the most important cardiology peer-reviewed international journals such as Circulation, JACC, JASE, American Journal of Cardiology, European Heart Journal and so forth. Anna serves as well, as Editorial Board Member of the Journal of the American Society of Echocardiography.
Administrative leadership
Kristen Chionh, MS, RD, CCRC
Administrative Director
Kris is the Director of Cardiovascular Research at Baylor Scott and White Health. A seasoned Clinical Research professional with over 20 years’ experience in the field, Kris works closely with physician leadership to direct administrative, operational and financial support of the Echo Core Lab.
Kris is a graduate of Indiana University, where she earned her Masters in Applied Health Science. She launched her career in clinical research in 2001 as a research coordinator and quickly rose to the ranks of Supervisor, Manager and Director. She joined Baylor Scott and White Health in 2012 as Research Supervisor for Endocrine Center, where she gained a name for her extraordinary skills in team development, leadership and exceptional abilities in problem solving. Eventually Kris was promoted to the position of Director of the Dallas Clinical Trials Office in 2017, and in 2018, she became the Director of Cardiovascular Research. In her capacity as the Director, she has successfully led several industry-sponsored trials and academic projects.
Sonographers
Marsha Roberts, ACS, RCS, RDCS, FASE
Marsha Roberts graduated from the Diagnostic Medical Sonography program at Weber State University in 1990. She started her career working for a mobile echo company and was soon hired as a cardiac sonographer for Intermountain Healthcare, eventually becoming the Director of Echo and Vascular Services for all Intermountain hospitals across the state of Utah. In 2010 Marsha moved to Dallas, Texas and started her own consulting business, Inside Echo, LLC. She facilitates IAC accreditation for adult and pediatric echo labs, vascular labs, and vein centers across the nation. Additionally, Marsha works as a core lab research sonographer for Baylor Scott & White at The Heart Hospital in Plano. She loves working with sonographers, physicians and administrators to enhance quality, facilitate accreditation and advance cardiac research.
Marsha is an active member of the Society of Diagnostic Medical Sonography and the American Society of Echocardiography (ASE), serving on numerous committees. She has been an invited faculty member every year at the ASE Scientific Sessions since 2004, most recently speaking on sonographer career pathways. Marsha has volunteered for Cardiovascular Credentialing International (CCI) since 2002 as a subject matter expert for the Registered Cardiac Sonography (RCS) exam, and is currently serving on CCI’s Executive Committee. In 2020 Marsha received the Weber State University Radiologic Sciences Award for Alumni of the Year.
In her leisure time, Marsha likes to travel with her husband and family. While traveling, they participate in outdoor activities including skiing, hiking, boating and scuba diving. Marsha is also an avid reader and enjoys spending time volunteering in her community.
Shabnam Pate, RDCS, RCS
Shabnam obtained her certification in cardiac ultrasound in 2003 and has stayed innovative and quality driven throughout her career. She joined Baylor as a PRN sonographer and rose quickly to lead the Non-Invasive Lab as its Technical Director. She is currently pursuing her Bachelors degree in both Biology and Business administration at the University of Texas at Dallas. She attends teaching education programs as well as visits different echocardiography labs across the nation to help them improve their contrast echocardiography.
Haji Mohammad, MS, MBBS, RDCS (AE, PE), RVT
Haji Mohammad graduated medical school from Jinnah Sindh Medical University in Karachi, Pakistan back in 1984. Upon graduating medical school, Haji completed an internship in both internal medicine and chest surgery. Haji eventually started his own internal medicine clinic where he treated patients.
After spending time as a physician in Pakistan, Haji decided to make the move to the United States. He started his journey in Longview, TX. Working at Christus Good Shepherd Medical Center, Haji focused on neonatal, pediatric, and adult cardiovascular sonography. He has been able to continue his sonography focus in Baylor Scott & White. He has been a part of the Baylor Scott & White system for nearly 14 years, with The Heart Hospital Baylor Plano since 2014.
Haji carries a Master’s degree in clinical Ultrasound from the University of Melbourne.
Kristie Faust Gomez, BS, ACS, RVT, RT(ARRT), FASE
Kristie Faust-Gomez has been a cardiac sonographer for over 20 years. She is currently the Outpatient Services Imaging department supervisor for Baylor Scott & White-The Heart Hospital in Plano Texas where she oversees cardiac and vascular ultrasound, CT, Cardiac Nuclear Imaging, and diagnostic radiology. Over the years Kristie has worked in various environments such as cardiology practices, outpatient clinics, structural heart centers, research, mobile sonography, and radiology. She has been a guest lecturer and assists in a cardiac sonography education program at her hospital.
Kristie is passionate about her profession focusing her efforts on quality improvement, research, and staff mentorship/education. She has many years of experience as the technical director of accredited echo labs. Kristie leads the imaging aspect of her hospital’s valve center, where they do TAVR, MitraClip and other advanced valve interventions. Kristie has been integral to the program which involves advanced echocardiographic and MDCT studies. She assists an international core laboratory with multiple clinical trials in valvular heart disease. She has initiated, organized, and managed a regional echocardiography symposium and has given lectures for her hospital’s fellows "boot camp." She is a teacher and leader within a large tertiary care healthcare system. Kristie is very involved in and oversees the youth cardiac screening program through her hospital and a non-profit organization to help bring awareness of sudden cardiac arrest in youth athletes. Kristie is also an active member of the American Society of Echocardiography and serves as a committee member.
Minnes Rosier, RDCS, RVT
With a nursing background and a fascination for Cardiology, Minnes began her career in Echocardiography in 1989. She received her cardiac ultrasound training through Presbyterian Healthcare System and a sonography internship at the University of Alabama in 1989. Minnes became a Registered Diagnostic Cardiac Sonographer in 1994 through the American Registry for Diagnostic Medical Sonography. Her interest in Vascular Medicine drove her to cross-train to become a Registered Vascular Technician through ARDMS after a few years. Minnes is currently a multi-modality sonographer, with breadth of knowledge in both cardiac and vascular image analysis.
Project management
Preethi Ravindranathan, MS
Project Manager
With a Bachelors degree in Industrial Biotechnology and a Masters in Biotechnology, Preethi joined the research scene in 2008 in UT Southwestern Medical center, Dallas. There she focused on designing and evaluating drugs to treat advanced cancers. After many fruitful years and publications in several top-ranked journals including Cancer Discovery and Nature Communications, she joined Baylor Scott and White Health to manage a biomarker research lab. Here she was opened to the world of clinical research. Intrigued, she joined the Clinical Research team to soak herself in the regulatory and project-management aspects of clinical research. Her flair for project management landed her in the world-class Cardiovascular team in The Heart Hospital Plano. Preethi joined the Echo Core Lab in 2020 and quickly became integral to the team.
Channing Wells, BS
Research Assistant
Channing Wells received her Associates Degree through a Dual Credit program at her high school. She then received her Bachelor of Science at the University of Texas at Arlington, majoring in Psychology and minoring in Biochemistry.
Publicaciones
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Guidelines and standards
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Zoghbi WA, Asch FM, Bruce C, Gillam LD, Grayburn PA, Hahn RT, Inglessis I, Islam AM, Lerakis S, Little SH, Siegel RJ, Skubas N, Slesnick T, Stewart WJ, Thavendiranathan P, Weissman NJ, Yasukochi S, Zimmerman K. Guidelines for the evaluation of residual valvular regurgitation after percutaneous repair or replacement. J Am Soc Echocardiogr 2019
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Relevant publications
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Grayburn PA, Sannino A, Cohen DJ, Kar S, Lim DS, Mishell JM, Whisenant BK, Rinaldi MJ, Kapadia SR, Rajagopal V, Crowley A, Kotinkaduwa LN, Lindenfeld J, Abraham WT, Mack MJ, Stone GW. Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial. J Am Coll Cardiol. 2020 septiembre 1;76(9):1007-1014. doi: 10.1016/j.jacc.2020.07.010.
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Sannino A, Sudhakaran S, Milligan G, Chowdhury A, Haq A, Szerlip M, Packer M, Grayburn P. Effectiveness of Medical Therapy for Functional Mitral Regurgitation in Heart Failure with Reduced Ejection Fraction. J Am Coll Cardiol. Accepted for publication on junio 2020.
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Grayburn PA, Packer M, Sannino A, Stone GW. Disproportionate secondary mitral regurgitation: myths, misconceptions and clinical implications. Heart. 2020 noviembre 24:heartjnl-2020-316992. doi: 10.1136/heartjnl-2020-316992.
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Grayburn PA, Sannino A, Packer M. Distinguishing Proportionate and Disproportionate Subtypes in Functional Mitral Regurgitation and Left Ventricular Systolic Dysfunction. JACC Cardiovasc Imaging. 2020 agosto 24:S1936-878X(20)30628-8. doi: 10.1016/j.jcmg.2020.05.043.
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Grayburn PA, Sannino A, Packer M. Proportionate and Disproportionate Functional Mitral Regurgitation: A New Conceptual Framework That Reconciles the Results of the MITRA-FR and COAPT Trials. JACC Cardiovasc Imaging. 2018 diciembre 6.
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Sannino A, Smith R III, Schiattarella GG, Trimarco B, Esposito G, Grayburn PA. Survival and Cardiovascular Outcomes of Patients with Secondary Mitral Regurgitation. A Meta-Analysis of 53 Studies. JAMA Cardiol. 2017 octubre 1;2(10):1130-1139.
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Sannino A, Stoler RC, Vallabhan R, Potluri S, Pollock B, Filardo G, Mack MJ, Grayburn PA. Assessment of the severity of paravalvular regurgitation and its role on survival after transcatheter aortic valve replacement. Structural Heart 2019; 3:24-30.
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Sannino A, Szerlip M, Harrington K, Schiattarella GG, Grayburn PA. Comparison of Baseline Characteristics and Outcomes in Men Versus Women With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. Am J Cardiol. 2018 enero 10. pii: S0002-9149(18)30040-7. doi: 10.1016/j.amjcard.2017.12.020. [Epub ahead of print] PubMed PMID: 29397106. IF 3.398
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Hamandi M, Smith RL, Ryan WH, Grayburn PA, Vasudevan A, George TJ,J. Michael DiMaio JM, Hutcheson KA, Brinkman W, Szerlip M, Moore DO, Mack MJ. Outcomes of isolated tricuspid valve surgery have improved in the modern era. Ann Thorac Surg 2019
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Grayburn PA, Oh JK, Reardon MJ, Popma JJ, Deeb GM, Boulware M, Huang J, Stoler RC. Effect of baseline aortic regurgitation on mortality in patients treated with transcatheter or surgical aortic valve replacement (from the CoreValve US Pivotal Trial). Am J Cardiol 2018; 122:1527-35.
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Contáctanos
Cardiac Imaging Core Lab (CICL)
Baylor Scott & White Research Institute
1100 Allied Drive, Suite 5-504
Plano, TX 75093
Paul A. Grayburn, MD, FACC, FASE, Medical Director
Phone: 469.814.4817
Email: Paul.Grayburn@BSWHealth.org
Anna Sannino, MD, PhD, FASE, Scientific Director
Phone: 469.867.8924
Email: Anna.Sannino@BSWHealth.org
Preethi Ravindranathan, MS, Project Manager
Phone: 469.814.4721
Email: Preethi.Ravindranathan@BSWHealth.org
Baylor Scott & White The Heart Hospital - Plano
1100 Allied Drive
Plano, TX 75093