Adult Echocardiography Core Laboratory

Adult Echocardiography Core Laboratory

The Adult Echocardiography Core provides high-quality cardiovascular imaging along with quantitative and qualitative imaging analysis for cardiovascular clinical trials and investigator initiated protocols. The Core faculty and staff offers expertise, materials, consultation, performs scanning and analysis on a fee for service basis.

The Core serves Investigators affiliated with the Medical College of Wisconsin. We provide consultation on image acquisition and analysis based upon American Society of Echocardiography (ASE) recommendations for the performance and evaluation of a comprehensive transthoracic echocardiogram, use of echocardiography in clinical trials and employ the ASE Standards for Echocardiography Core Laboratories.

Successful and timely scanning and data analysis requires a concerted, collaborative effort of the Investigator and the Core staff in all stages of the study. Investigators planning on utilizing Core services are therefore encouraged to contact the staff early in the planning stages of the study.

About the Core

About the Core

Consultation services are provided by one of two board-certified cardiologists with extensive backgrounds in cardiac imaging and clinical research. As one of the largest medical research facilities in Wisconsin, we are able to offer a wide range of expertise in cardiac and vascular imaging. The Medical Director of the Echo Core Lab, Jennifer Strande, MD, PhD provides consultation with investigators to optimize the acquisition of data and provide qualitative and quantitative results for a clinical trial or research study while maintaining compliance with regulatory guidelines.

Echocardiography is the cornerstone of the cardiovascular structure and hemodynamic assessment. Its highly versatile nature makes it the non-invasive tool of choice. This form of non-invasive assessment is ideal for performing serial evaluations of cardiac function or real-time monitoring during and after pharmacological or therapeutic intervention. Echocardiography has the versatility that allows for rapid and comprehensive evaluation of cardiac structure, myocardial function, valvular hemodynamics and vascular structure. Protocols are adaptable to the needs of the investigator.

COMPLIANCE, CONFIDENTIALITY AND QUALITY ASSURANCE

All Core Lab studies follow the American Society of Echocardiography (ASE) Recommendations for the use of Echocardiography in Clinical Trials (JASE, 2004; 17:1086-1119) and the ASE Standards for Echocardiography Core Laboratories (JASE, 2009; 22:755-765.)

Standard Operating Procedures and protocols are unique to every study. Imaging protocols are developed upon consultation with the Principal Investigator or in accordance with sponsor written protocols.

A dedicated scanning room for all ultrasound studies to ensure subject comfort and privacy is located in the Clinical and Translational Science Institute on the Medical College of Wisconsin/Froedtert Health Campus. In addition, a state-of-the-art Xcelera workstation is used for image analysis. This system allows import of DICOM compatible data and performs advanced imaging analysis such as: 3D, Advanced 3D Quantification, 2D and Doppler Strain and IMT.

To maintain confidentiality, subject records/data are stored in a locked cabinet in the Echo Core Lab office and on Medical College of Wisconsin Corporate password protected computers. Only investigators and study staff identified on an approved Institutional Review Board protocol are authorized access to study specific documents and data.

All ultrasound studies are preliminarily reviewed by a Registered Diagnostic Cardiac Sonographer with the final interpretation made by a board certified Cardiologist to ensure accuracy of the final report. We are able to provide blinded analysis for your study.

Services

Adult Echocardiography Core Laboratory Services

Comprehensive Screening Echocardiogram

Comprehensive Screening Echocardiogram: Non-invasive transthoracic cardiac ultrasound exam that includes 2D, pulse-wave Doppler, continuous-wave Doppler, color Doppler and tissue Doppler imaging. The Adult Core Lab follows the American Society of Echocardiography Guidelines for performance of a comprehensive transthoracic echocardiography examination including chamber quantification, Doppler echocardiography, valve hemodynamics and diastolic function.

Data provided at the study end: Comprehensive echocardiogram report with multiple echo parameters including:

  • Demographic information
  • Systolic function
  • Evaluation of cardiac structures
  • Diastolic function
  • LV size and volume in end-systole and end-diastole
  • Valve morphology and hemodynamics
  • Wall thickness and mass
  • Chamber quantification
  • RV size and function
  • Wall motion analysis

SERIAL SCREENING ECHOCARDIOGRAM

Serial Screening Echocardiogram: Echocardiograms that must occur within specific windows and must be repeated on the subject at a specific later date. Includes all the analysis of a screening echocardiogram at each echo date.

LIMITED 2D ECHOCARDIOGRAM FOR LEFT VENTRICLE FUNCTION

Limited 2D Echocardiogram for Left Ventricle Function: When the echo protocol specifies left ventricle ejection fraction only, a limited study may be performed. Valve hemodynamics and diastolic function are not included in a limited 2D study.

Data provided at the study end: Echo report with demographic information, evaluation of cardiac structures, chamber sizes, left ventricle ejection fraction, wall thickness, left ventricle end-diastolic and end-systolic volumes, and valve morphology.

SALINE CONTRAST ECHOCARDIOGRAM

Saline Contrast Echocardiogram: Saline contrast echocardiography is a reliable non-invasive method for detection of intra-atrial or pulmonary right-to-left shunting. This study may be added to either a Screening Echocardiogram or a Limited 2D Echocardiogram. For subject safety, a Limited 2D echocardiogram is required prior to administration of agitated saline.

Data provided at the study end: Echo report with demographic information, evaluation of cardiac structures, chamber sizes, left ventricle ejection fraction, wall thickness, left ventricle end-diastolic and end-systolic volumes, valve morphology and if detected, quantification of right-to-left shunting following resting saline contrast injection and injection with Valsalva maneuver.

TRANS-PULMONARY CONTRAST STUDIES FOR MYOCARDIAL PERFUSION OR FUNCTION

Trans-pulmonary Contrast Studies for Myocardial Perfusion or Function: Trans-pulmonary contrast agents traverse the pulmonary capillary bed to opacify the left ventricle and enable segmental wall motion analysis or quantify myocardial perfusion of LV segments.

Data provided at the study end: Echo report with demographic information, evaluation of cardiac structures, chamber sizes, left ventricle ejection fraction, wall thickness, left ventricle end-diastolic and end-systolic volumes, valve morphology. Trans-pulmonary contrast studies may be combined with either a Screening Echocardiogram or Limited 2D Study. For subject safety, a Limited 2D Echocardiogram is required prior to administration of contrast agents.

CAROTID INTIMA-MEDIA THICKNESS (CIMT)

Carotid Intima-Media Thickness (IMT): Ultrasound scanning is used to delineate the carotid artery. A dedicated IMT quantification program is utilized for quantitative analysis of the IMT.

Data provided at the study end: Customized depending upon discussion with PI.

CUSTOMIZED ECHOCARDIOGRAPHY

Customized Echocardiography: Includes studies that the core staff and the PI have discussed in detail and that are not offered on a routine basis. Analysis and data reporting will be included.

Data provided at the study end: Customized depending upon discussion with PI.

STRAIN/STRAIN RATE ANALYSIS OF LEFT VENTRICLE

Strain Analysis of Left Ventricle: 2D speckle tracking echocardiography is a novel technique that enables the assessment of myocardial strain through the analysis of speckle motion inherently present in a standard, 2D echocardiographic image. This technique is angle independent and preload independent. It is not affected by tethering between segments and less operator dependent. This technique has been validated in experimental and human studies and found to correspond well to established “gold standard” techniques.

Why use strain imaging for your study:

  • Strain has increased sensitivity in detecting LV systolic dysfunction when compared to conventional LV function analysis (i.e. ejection fraction and fractional shortening)
  • Strain analysis is better suited for regional wall motion abnormalities
  • Speckle tracking-derived strain correlates with the degree of cardiac fibrosis

Data provided at the study end: Spreadsheet with quantitative regional and global strain values.

Strain Rate Analysis of Left Ventricle
Why analyze strain rate for your study:

  • Diastolic strain rate may be used as an additional surrogate of ventricular fibrosis and segmental relaxation abnormalities.
  • By providing insight into regional diastolic function, segmental diastolic strain rate can readily uncover the presence and extent of regional ischemia and viability.

Data provided at the study end: Spreadsheet with quantitative regional and global strain rate values.

DOPPLER ANALYSIS OF DIASTOLIC FUNCTION, TRANSVALVULAR VELOCITIES AND VALVE REGURGITATION

Doppler Analysis of Diastolic Function, Transvalvular Velocities and Valve Regurgitation: We routinely assess LV diastolic function based on Doppler-derived parameters: E/e’, E/A, Vp, and IVRT/RR. Doppler is also used to assess transvalvular velocities and regurgitant lesions. We can use Doppler measurements to quantify the severity of obstructive or regurgitant valve lesions.

Resources

Resources

Philips iE33 cardiovascular ultrasound system from Philips Healthcare
This system includes an S5-1 sector transducer, an L11-3 linear array transducer and an X3-1 matrix transducer for 3D image acquisition. Features include harmonic imaging, M-mode, tissue velocity imaging, spectral Doppler, color flow Doppler, 4D and ECG gated 3D imaging.

Philips iE33 cardiovascular ultrasound system from Philips Healthcare

Xcelera Focus Workstation
The Xcelera Focus workstation includes offline analysis of IMT, strain, Tissue Motion Quantification (TMQA), and 3D assessment of cardiac structure and function.

Xcelera Focus Workstation

GE Vivid 7 cardiovascular ultrasound system from GE Healthcare
This system includes an M3S sector transducer. Features include coded harmonic imaging, real-time anatomical M-mode, 2D speckle tracking (strain) imaging, tissue velocity imaging, spectral Doppler, and color flow Doppler.

GE Vivid 7 cardiovascular ultrasound system from GE Healthcare

EchoPAC with Q analysis system
The EchoPAC with Q analysis system is available for offline analysis.

EchoPAC with Q analysis system
Protocols

Protocols

Echocardiography protocols are developed in accordance with guidelines and standards published by the American Society of Echocardiography.  Upon consultation with the Core Medical Director imaging parameters are designed.  Studies for clinical trials are performed in accordance with the sponsor supplied protocol with report/data transfer as specified.

View ASE Guidelines and Standards

MCW Echo Core Lab
References

References

MANUSCRIPTS

Migrino, R, Harmann, L, Woods, T, Bright, M, Turan, S, Hari, P.  Intraventricular dyssynchrony in light chain amyloidosis: a new mechanism of systolic dysfunction assessed by 3-dimensional echocardiography.  Cardiovascular Ultrasound, 2008, 6:40

Artang, R, Migrino, R, Harmann, L, Bowers, M, Woods, T.  Left Atrial Volume Measurement with Automated Border Detection by 3-Dimensional Echocardiography: Comparison with Magnetic Resonance Imaging.  Cardiovascular Ultrasound, 2009, 7:16.

Migrino, R, Mareedu, R, Eastwood, D, Bowers, M, Harmann, L, Hari, P.  Left Ventricular Ejection Time Predicts Long-Term Mortality in Light Chain Amyloidosis.  Journal of the American Society of Echocardiography, 2009; 22: 1396-402.

La Disa, J, Bowers, M, Harmann, L, Prost, R, Doppalapudi, A, Mohyuddin, T, Zaidat, O, Migrino, R.  Time-Efficient Patient-Specific Quantification of Regional Carotid Artery Fluid Dynamics and Spatial Correlation with Plaque Burden.  Medical Physics, 2010, 37:2, 784-792.

Migrino, R, Ahn, KW, Brahmbhatt, T, Harmann, L, Jurva, J, Pajewski, N.  Usefulness of Two-Dimensional Strain Echocardiography to Predict Segmental Viability Following Myocardial Infarction and Optimization Using Bayesian Logistic Spatial Modeling. American Journal of Cardiology, 2009 104:1023-1029

Drews, B, Harmann, L, Beehler, L, Bell, B, Drews, R, Hildebrandt, T.  Ultrasonographic monitoring of fetal development in unrestrained bonobos (Pan Paniscus) at the Milwaukee County Zoo.  Zoo Biology, 2010, 28: 1-12

Migrino, R, Mareedu, R, Eastwood, D, Bowers, M, Harmann, L, Hari, P.  Left Ventricular Ejection Time Predicts Long-Term Mortality in Light Chain Amyloidosis.  Journal of the American Society of Echocardiography, 2009; 22: 1396-402.

Woods, T, Harmann, L, Purath T, Ramamurthy, S, Subramanian, S, Jackson, S, Tarmina, S.  Small and Moderate Size Right-to-Left Shunts Identified by Saline Contrast Echocardiography are Normal and Unrelated to Migraine Headache.  Chest 2010;138 264-269.

Migrino, R, Bowers, M, Harmann, L, Prost, R, LaDisa, J.  Carotid Plaque Regression Following 6-Month Statin Therapy Assessed By 3T MRI: comparison with Ultrasound Intima Media Thickness.  Journal of Cardiovascular Magnetic Resonance, 2011, 13:37.

Migrino, R, Harmann, L, Christenson, R, Hari, P. Clinical and Imaging Predictors of 1-year Long-Term Mortality in Light Chain (AL) Amyloidosis: A 5-year Follow Up Study. Heart and Vessels, In process, Accepted for publication September 26, 2013.

ABSTRACTS

Wilson, N, Migrino, R, Harmann, L, Prost, R, LaDisa, J.  Modeling and Realistic Simulation of the Carotid Artery Bifurcation Using 3-D Image Segmentation Implemented in a Commercial Software Package for Hemodynamic Simulation (CVSIM™).  Abstract presentation at the ASME 2008 Summer Bioengineering Conference, Marco Island, FL.  June 2008.

LaDisa, J, Prost, R, Harmann, L, Mohyuddin, T, Zaidat, O, Jurva, J, Doppalapudi, A, Bright, M, Migrino, R.  Patient Specific Computational Simulations of Carotid Artery Hemodynamics Complement Clinical Imaging Data and Correlate with Plaque Morphology after Statin Treatment.  The Fifth International Biofluid Symposium and Workshop at Caltech.  2008

Sheik, A, Harmann, L, Woods, T.  Hospitalists Can be Rapidly Trained to Use Hand-Held Echocardiography to Avert Costly Repeat Echocardiograms.  Top Ten National Associates Competition Abstract Presentation.  American College of Physicians – Internal Medicine 2008.  Washington, DC.  May 2008.

Bowers, M, Harmann, L, Prost, Robert, Bright, M, Doppalapudi, A, Mohyuddin, M, LaDisa, J, Migrino, M.  Underestimation of Carotid Plaque by Ultrasound IMT and Potential Error in Measurement of Change in Plaque Burden: Simultaneous Comparison with 3T MRI.  Abstract presentation Society for Cardiovascular Magnetic Resonance. Orlando, FL. 2009

Bowers, M, Harmann, LMigrino, R. Carotid Plaque Regression Following 6-Month Statin Therapy Assessed by 3T MRI: Comparison With Ultrasound IMT, Presentation at Northwester Cardiovascular Young Investigators’ Forum, Chicago, IL. September, 2009

Migrino, R, Harmann, L, Prost, R, Bowers, M.  Relating Carotid Plaque Volume Reduction Assessed by 3T MRI with Inflammatory Cytokine Change Following 6 Month Statin Treatment.  Abstract presentation at American College of Cardiology Scientific Sessions, Atlanta, GA.  2010

Zach, K, Papanek, P, Szabo, A, Harmann, L, Hoch, A.  Is Heart Dysfunction Related to Amenorrhea?  American Medical Society for Sports Medicine, Salt Lake City, UT. May 2011

Wang, K, Harmann, L, Visotcky, A Tarima, S, Woods, T.  ASE Recommended Left Atrial Volume Measurements Overestimate Disease.  Medical College of Wisconsin M1 Summer Research, Milwaukee, WI. September 2011.

Woods, T, Wang, K, Harmann, L, Visotcky, A, Tarima, S.  Standard Left Atrial Volume Scale Overestimates Disease.  American College of Cardiology, Chicago, IL.  March 2012.

Migrino, R, Harmann, L, Christenson, R, Hari, P.  Left Ventricular Ejection Time, but not Late Gadolinium Enhancement is an Independent Predictor of Long-Term Survival in AL Amyloidosis: A 5-Year Follow Up. American Heart Association Scientific Sessions, Los Angeles, CA. November 2012.

Woods, T, Harmann, L, Visotcky, A, Tarima, S. The Pathophysiological Link Between PFO and Migraine Headache. American College of Cardiology, San Francisco, CA. March 2013.

Fees

Fees

ELECTROCARDIOGRAM SERVICES

Hourly rates are invoiced in 15 minute increments, and mileage @ the current IRS limit is added to the invoice, when applicable.

  • EKG (INTERPRETED)

    Per Test per Participant - Interpretation charge per CVC / Internal or External CTSI Principal Investigator & For-Profit Sponsor

    $10
  • EKG (NOT INTERPRETED)

    Per Test per Participant / Internal or External Non-Profit or For-Profit Sponsor

    Waived

Last updated: 08/02/2016 @ 5:01:12 PM

Ultrasound Services

Hourly rates are invoiced in 15 minute increments, and mileage @ the current IRS limit is added to the invoice, when applicable.

  • CTSI PRINCIPAL INVESTIGATOR & FOR-PROFIT SPONSOR

    $60/hour
  • CTSI PRINCIPAL INVESTIGATOR & NON-PROFIT SPONSOR

    $60/hour
  • Non-CTSI Principal Investigator & NON-PROFIT SPONSOR

    $90/hour
  • NON-CTSI PRINCIPAL INVESTIGATOR & FOR-PROFIT SPONSOR

    $120/hour

Last updated: 08/02/2016 @ 5:01:12 PM

Equipment Use
  • Vivid 7

    $7.50/hour
  • EchoPAC

    $7.50/hour
  • Philips iE33

    $7.50/hour

Last updated: 08/02/2016 @ 5:01:12 PM

TRU Terms & Attestations

TRU Terms & Attestations

Terms

  • The TRU requires a fully signed Letter of Agreement (LOA) and a copy of the Institutional Review Board (IRB) Approval letter before the study may begin.
  • Cancellation of Requested Services: Please provide notice of at least 48 hours for cancellation of requested services. Should short-notice or no-notice cancellations become frequent or habitual we reserve the right to charge for such scheduled services.
  • Scheduling of Requested Services: Availability is to the best of our ability with variables including but not limited to: already scheduled services for this or any other study, availability of appropriate staff, and availability of appropriate physical space.
  • The TRU fees are subject to change. Every effort will be made to minimize the amount and frequency of such changes.
  • Pass through fees from external contractors (ex. external laboratory fees) are subject to change should the external contractor fees change.
  • As a practice, the TRU will keep and maintain copies of all study related documents which will be turned over to the Principal Investigator at the time of study closure.
  • As a CTSI Investigator, you agree to participate in the TRU’s annual satisfaction survey process.
  • Should additional services be requested, a new proposal may be created to outline the scope of the request and associated cost-sharing fees. This LOA will be amended as necessary.
  • If any changes are made in your protocol, it is the study team’s responsibility to provide any updated IRB approved forms and review any procedural changes with the A-TRU Nurse Manager prior to the next participant’s scheduled visit.
  • The TRU will bill on a monthly basis for all services rendered.
  • Payment for services performed will be expected upon receipt of a billing statement. Statements for ongoing services will be submitted on a monthly basis. Payment instructions will be included on the statements. Our Program Associate will be in touch with you to obtain contact information for invoicing.

Attestations

  • On behalf of the department/division/institute or other professional jurisdiction that you represent, you attest that all of the following conditions have been satisfied:
    • The Principal Investigator is a faculty member, credentialed physician, licensed nurse or licensed pharmacist (as applicable) in good standing;
    • The Principal Investigator is approved to devote the proposed time and effort to this project;
    • If the Principal Investigator’s application identifies Department/Division/Institute funds to support this project, this Department/Division/Institute endorses this commitment;
    • The project has scientific merit, uses procedures consistent with sound research design, and is likely to yield the expected knowledge; and
    • The proposal is a complete and coherent one.
  • You agree to cite the CTSA NIH Grant UL1TR001436 and if applicable KL2TR001438 on all publications arising from any research project receiving support from the CTSI. Publications arising from any research project receiving support from the CTSI must acknowledge such support by stating the following:
    • “Support received by grant UL1TR001436 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences.”
    • KL2 Scholars: “Support received by grants UL1TR001436 and KL2TR001438 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences.”

Request Services

Request Services

Request Adult Echo Core Lab Services below to establish timeline and to review the experimental design.

Request Adult Echocardiography Core Services

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Contact Us

Contact Us

Leanne Harmann, BA, RDCS, RDMS, RVT

Leanne Harmann, BA, RDCS, RDMS, RVT (Primary Contact)
Core Technical Director and Sonographer
voice: (414) 805-7205
fax: (414) 955-6203

Jennifer Strande, MD, PhD

Jennifer Strande, MD, PhD
Core Medical Director
voice: (414) 456-7568
fax: (414) 456-6515

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NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

Zablocki VA Medical CenterMedical College of WisconsinMSOE