The CVI Core Lab at the Cleveland Clinic Foundation Heart Center analyzes echocardiographic information from clinical trials and studies.

Why use a central echo lab?

The purpose of the Core Lab is:

• to provide an unbiased interpretation of the results of echocardiographic images obtained in pharmaceutical or device research studies,
• to reduce inter-observer variability and increase the accuracy and precision of the results,
• to establish an oversee compliance with echocardiographic protocol guidelines; and
• to provide quality assurance of echocardiograms and the associated data.

Capabilities

The physicians and sonographers at Cleveland Clinic Foundation:

• are recognized nationally and internationally as leaders in all of the main fields of echocardiography
• are uniquely qualified to quantitatively analyze echocardiographic research studies
• use a consistent set of definitions and have the training required to perform quantitative wall motion, function, strain analysis, Euler equation and valvular assessments.

Our Core Lab increases accuracy and reproducibility of interpreted results by decreasing inter-observer variability through consistent training and systematic analytical processes and blinding to the randomization sequence.

Echocardiograms are measured using American Society of Echocardiography guidelines. Senior registered/registry eligible sonographers do quantitative measurements. Board-certified cardiologists with advanced training in echocardiography interpret the echocardiograms.

The medical directors provide direction to the technical director, review video/digital echocardiograms, disseminate information on new trends and analysis procedures, meet with current and potential project sponsors, present core lab data at national and international meetings and write articles for journal submissions.

The technical director is responsible for the day-to-day operation of the Core Lab, including supervision of employees, project management, quality control, echo review and adjudication, and methodologies. The technical director also travels to meetings to represent the Core Lab in protocol discussions, clinical trial management, and site initiation and maintenance.

Research personnel will be responsible for the coordination of individual trials, including developing trial databases, creating Core Lab case report forms for site initiation packets, direct communication with clinical trial coordinators, detecting and reporting protocol violations, and periodic communication with study sponsors. They provide echocardiographic analysis at the primary, secondary, and adjudication levels.

Our experience

The Echo Core Lab has significant experience in providing analysis for clinical echocardiographic trials. Our experience ranges from studies as small as 40 to as large as 4000 echocardiographic exams. This experience includes but is not limited to:

• assessment of left ventricular mass, left ventricular function
• wall motion scoring and analysis
• echocardiographic analysis of drug and/or device trials
• transpulmonary echo contrast grading and analysis
• valve repair/replacement
• electrophysiology devices
• heart failure/heart transplantation
• intra-operative trials involving ventricular assist devices
• aortic atheroma
• prosthetic valves
• other areas include neurology, oncology and hypertension studies

Additionally, the Core Lab is the coordinating center for the ACUTE Trial (Assessment of Cardioversion Utilizing Transesophageal Echocardiography) a multi-center trial with over 50 national and international sites, ACUTE II and the CLOTS study. The CVI Core Lab is also involved in analysis of echocardiography in basic research.

Cardiovascular Imaging Core Lab Variability and Quality Assurance

Variability is introduced during many stages of the analysis process to improve quality and information accuracy:

Echocardiographic protocols are developed and customized for each project. These protocols instruct the collaborating centers on the minimum echocardiographic requirements for patients in the trial

To improve accuracy, each site is provided with pre-labeled videotapes and/or optical disks along with a Patient Data Mailing/Tracking form. Each shipment of videos/disks received is examined closely to eliminate the possibility of analyzing the wrong patient or film. Sites are contacted immediately for clarification if echocardiograms received by the Core Lab are not in total agreement with the accompanying paperwork.

All information is devoid of any reference to drug or device regiment, thus insuring blinding of the Core Lab.

Internal variability is controlled through a system of checks and tests. Two independent reviewers analyze ten percent of the echocardiographic studies; any discrepancies are either adjudicated between the two reviewers or by a third independent viewer. In the event a consensus cannot be reached during this process, the technical director or one of the medical directors assists with the analysis.

Through the use multiple blinded reviewers and the adjudication process, analysis variability of subjective readings is significantly reduced. The medical directors review all difficult or unique cases, in addition to analyzing a predetermined subset of echocardiograms for quality assurance. Source documentation is kept on site to assist with data integrity and Core Lab queries and audits.

Dedicated core lab echocardiographic equipment consists of cutting-edge ultrasound imaging instruments, super- VHS video player/recorders, industrial grade color video monitors, digital frame grabbers, digital image archiving (storage/retrieval), digital imaging network, and high quality grade color page printers.

For more information, contact:
Annitta J. Morehead, RDCS
Technical Director
Core Lab and Clinical Trials
Imaging Section of Cardiology
The Cleveland Clinic Foundation, F15
9500 Euclid Avenue
Cleveland, Ohio 44195

216/445-7673 office
216/445-4419 fax
morehea@ccf.org

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