Echo Core Lab

The BCRI Echo Core Lab Berlin is an academic image analysis center for scientific research investigations in clinical trials with echocardiographic endpoints. It provides the whole spectrum of echo related services for all phases of clinical trials including protocol development, statistical support, training and certification of sonographers, and echocardiographic image analysis and interpretation.

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Echo Core Lab

As part of the Charité Berlin Division of Cardiology our team has gathered comprehensive experience in different multicenter clinical trials and diverse research projects. Comprehensive training of sonographers, a thorough certification process and an algorithm of reading and overreading by experienced investigators ensure a high level of data quality and reproducibility.

In addition to the full range of conventional echocardiographic measurements we provide state-of-the-art analysis techniques such as strain analysis with speckle tracking and 3D/4D echocardiography. Another focus of our team is stress echocardiography for which we provide the same range of services as for resting echo (development of stress echo protocols, training sessions, centralized offline data analysis, etc.).

Services

The Echo Core Lab offers a wide range of services related to the analysis of medical images.

Participation in trial / substudy design

Assistance in the development of study specific documents is one of the initial services we provide for our customers before the start of the clinical trial. We provide assistance in the development of:

  • clinical study protocol
  • eCRF (electronic case report forms)
  • sonographer manual
  • study analysis plan
  • study specific SOPs for data handling and analysis

Training and certification

  • In most clinical trials with imaging endpoints sonographers need to be trained before they are eligible for recording patient echos. We provide on-site training and on-line training (using videos, web-based training sessions).
  • To complete the certification process sonographers submit an evaluation echo study, which is analyzed by our readers to provide real-time feedback.
  • If study specific requirements are fulfilled (e.g. all required views are recorded) and the quality of the recorded echo meets our specified quality criteria the sonographer receives a certification document.

Image Reading

  • Our core business is providing high quality echocardiographic image analysis in accordance with the study specific analysis plan.
  • Under certain conditions ad hoc image analysis by our core lab (e.g. verification of inclusion criteria) may be required.
  • After the initial reading, an additional reading check ("overreading") is done by our most experienced team members.

Facilities

For analysis of imaging data the Echo Core Lab Berlin uses TomTec analysis software (TomTec Imaging Systems GmbH, Unterschleissheim, Germany).


Team

Dr. Elisabeth Pieske-Kraigher
is Managing Director of the Echo Core Lab Berlin. She has extensive expertise in the field of echocardiography including echo reading and overreading. She trained as clinical sonographer at the Department of Cardiology, Medical University Graz, Austria, Harvard Medical School Boston, and Charité Berlin. She obtained in-depth additional training in 2012 and 2013 as a fellow at the Imaging Core Lab (ICL), Brigham and Women's Hospital, Harvard, Boston, USA under the supervision of Prof. Scott Solomon and Prof. Marc Pfeffer. At the ICL Harvard, she was responsible for overreading processes for images of ongoing clinical heart failure trials and the certification of sonographers. She gained intensive experience in novel echocardiographic techniques including strain and strain rate, and 3D speckle tracking and was responsible for training new team members. In 2014 she began establishing the central Echo Imaging Core Lab at Charité Universitätsmedizin Berlin with successful internationl auditing.In her position as Managing Director of the ECL Berlin Dr. Pieske-Kraigher has since been responsible for central reading, analysis and data quality control of a number of international clinical trials sponsored by industry, the European Commission, and German funding authorities. She is the author of numerous peer reviewed articles (published under her maiden name Dr. Elisabeth Kraigher-Krainer).

Dr. Belyavskiy
is a cardiologist with broad noninvasive cardiovascular imaging experience. He has extensive expertise in echocardiographic analyses in clinical trials and is currently involved in echocardiographic research projects focused on diastolic stress echocardiography and heart failure with preserved ejection fraction.

Aravind Kumar Radhakrishnan
is a medical doctor with broad noninvasive cardiovascular imaging experience and specific expertise in research related to echocardiography and cardiac imaging studies. He is working on a number of completed and ongoing clinical trials and is currently doing his doctorate at the Charité – University Medicine.

Dr. Daniel A. Morris
is a cardiologist with wide ranging experience in echocardiography certified by the European Association of Cardiovascular Imaging (EACVI Certification in Adult Transthoracic Echocardiography) and with a university specialization in echocardiography (Université Paris XII – Diplôme Inter Universitaire). Dr. Morris is highly involved in clinical echocardiographic research with a focus in new echocardiographic methods and speckle tracking echocardiography. These are the topics of his recent publications and his doctoral thesis at the Charité – University Medicine.

Robin Kraft
is a medical doctor specialized in clinical research echocardiography. He divides his time between the Echocardiographic Department of Charité – University Medicinel and the Echo Core Lab Berlin. Dr. Kraft is currently involved in different research projects on new echocardiographic methods in heart failure patients.

Mr. Kropf's, MSc
research interest is data mining and predictive modeling. He is currently doing his PhD at the Institute for Semantic Data Analysis and Knowledge Discovery, Technical University Graz, Austria. His daily business in the lab involves close collaboration with the clinical researchers, data management, providing guidance in technical issues, data analysis and protocol development.


Ongoing Trials

SOCRATES-PRESERVED
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure
ClinicalTrials.gov Identifier: NCT01951638
 
SOCRATES-REDUCED
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
ClinicalTrials.gov Identifier: NCT01951625
 
Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure (OptimEx) – TU München
ClinicalTrials.gov Identifier: NCT02078947
 
Exercise Training in Diastolic Heart Failure (Ex-DHF) – University of Göttingen

Barostim Therapy™ in Heart Failure with Preserved Ejection Fraction – (BaroStim) – CVRX

Key Publications

Kraigher-Krainer E, Shah AM, Gupta DK, et al. Impaired systolic function by strain imaging in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2014;63:447-56.

Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, et al. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014;16:1026-38.

Suchy C, Massen L, Rognmo O, Van Craenenbroeck EM, Beckers P, Kraigher-Krainer E, et al. Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial. Eur J Prev Cardiol. 2014;21(2 Suppl):18-25.

Morris DA, Krisper M, Nakatani S, et al. Normal range and usefulness of right ventricular systolic strain to detect subtle right ventricular systolic abnormalities in patients with heart failure: a multicentre study. Eur Heart J Cardiovasc Imaging. 2016; doi:10.1093/ehjci/jew011.

Ma XX, and Morris DA. Clinical relevance of left atrial strain to predict recurrence of atrial fibrillation after catheter ablation: a meta-analysis. Echocardiography 2016; doi: 10.1111/echo.13184.

Gheorghiade M, Greene SJ, Butler J, Filippatos G, Lam CS, Maggioni AP, Ponikowski P, Shah SJ, Solomon SD, Kraigher-Krainer E, et al. Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction: The SOCRATES-REDUCED Randomized Trial. JAMA. 2015;314:2251-62.

Morris DA, Blaschke D, Krebs A, Canaan-Kühl S, Plöckinger U, Knobloch G, Walter TC, Kühnle Y, Boldt LH, Kraigher-Krainer E, et al. Structural and functional cardiac analyses using modern and sensitive myocardial techniques in adult Pompe disease. Int J Cardiovasc Imaging. 2015;31:947-56.

Belyavskiy E, Morris DA, Kraigher-Krainer E, et al. Clinical perspectives and evidence of diastolic stress test in heart failure with preserved ejection fraction. The Egyptian Heart Journal 2015; 67: 279–288.

Kropf M, Modre-Osprian R, Gruber K, et al. Evaluation of a clinical decision support rule-set for medication adjustments in mHealth-based heart failure management. Stud Health Technol Inform. 2015;212:81-7.

Morris DA, Takeuchi M, Krisper M, et al. Normal values and clinical relevance of left atrial myocardial function analysed by speckle-tracking echocardiography: multicentre study. Eur Heart J Cardiovasc Imaging. 2015;16:364-72.

Contact

Charité-University Medicine Berlin
Campus Virchow-Klinikum (CVK)
Medical Department, Division of Cardiology
Mittelallee 2
Augustenburgerplatz 1
13353 Berlin

t: +49 30 450 565 496
f: +49 30 450 7 565 496
E-Mail