BSWRI Cardiac Imaging Core Lab (CICL)

 

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.

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).

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.

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.

Guidelines and Standards:

• 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

Relevant Publications

• 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 Sep 1;76(9):1007-1014. doi: 10.1016/j.jacc.2020.07.010.
• 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 June 2020.
• Grayburn PA, Packer M, Sannino A, Stone GW. Disproportionate secondary mitral regurgitation: myths, misconceptions and clinical implications. Heart. 2020 Nov 24:heartjnl-2020-316992. doi: 10.1136/heartjnl-2020-316992.
• Grayburn PA, Sannino A, Packer M. Distinguishing Proportionate and Disproportionate Subtypes in Functional Mitral Regurgitation and Left Ventricular Systolic Dysfunction. JACC Cardiovasc Imaging. 2020 Aug 24:S1936-878X(20)30628-8. doi: 10.1016/j.jcmg.2020.05.043.
• 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 Dec 6.
• 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 Oct 1;2(10):1130-1139.
• 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.
• 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 Jan 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
• 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
• 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.