1. Events
  2. Community Events
  3. Standardized Data Collection for Cardiovascular Imaging

Standardized Data Collection for Cardiovascular Imaging

September 26, 2011

The Standardized Data Collection for Cardiovascular Imaging meeting in Silver Spring, MD was held by the U.S. Food and Drug Administration to discuss goals of standardization for cardiovascular image recording. See below in the agenda table for a list of topics discussed.

#

Time

Speaker

Topic

1

9:00 – 9:05 a.m.

Karen A. Hicks, M.D.
Medical Officer
Division of Cardiovascular and
Renal Products
Center for Drug Evaluation and Research (CDER) / FDA

Welcome

2

9:05 – 9:15 a.m.

Norman L. Stockbridge, M.D., Ph.D.
Director
Division of Cardiovascular and
Renal Products
Center for Drug Evaluation and Research (CDER) / FDA

Opening Remarks

3

9:15 – 9:25 a.m.

Karen A. Hicks, M.D.

Goals of the Standardized Data Collection for Cardiovascular Imaging Initiative

4

9:25 – 9:45 a.m.

James E. Tcheng, M.D.
Director, Bioinformatics Core, Duke Translational Medicine Institute
Medical Knowledge Architect, Duke Health System
Co-Chair, American College of Cardiology (ACC) Informatics Committee

Shari Targum, M.D.
Medical Officer
Division of Cardiovascular and
Renal Products
(CDER) / FDA

What is Informatics?  Why do we need data elements?

 

 

 

Moderator

5

9:45 – 10:05 a.m.

Brian McCourt
Associate Director
Clinical Research Informatics
Duke Clinical Research Institute (DCRI)

and

Meredith Nahm, PhD
Associate Director
Duke Center for Health Informatics
Principle Investigator, FDA R24
Synthesis & Harmonization of High Impact Data Elements

Chris Tolk
Director, Terminology
Clinical Data Interchange Standards Consortium (CDISC)

Cardiovascular Data Elements Roadmap:  Process and Players

 

 

 

 

 

 

Moderator

6

10:05 – 10:25 a.m.

Robert C. Hendel, M.D.
Chairman, ACC/AHA Task Force on Data Standards

Director, Cardiovascular Intensive Care Unit; Director of Cardiac Imaging and Outpatient Services;
Cardiovascular Division
University of Miami Miller School of Medicine
University of Miami Hospital

Pamela Woodard, M.D., FACR (ACR/AHA/NASCI)
Mallinckrodt Institute of Radiology
Saint Louis, MO

Coordination of Cardiac Imaging Data Standards:  The Professional Society Viewpoint

 

 

 

 

Moderator

7

10:25 – 10:45

BREAK

 

8

10:45 – 11:15

Pamela S. Douglas, M.D.
Ursula Geller Professor of Research in Cardiovascular Diseases
Director, Imaging Program
Duke Clinical Research Institute
Duke University
Past President, American College of Cardiology

Robert O. Bonow, M.D.
Goldberg Distinguished Professor of Cardiology
Director, Center for Cardiovascular Innovation
Northwestern University Feinberg School of Medicine

Scope, Organization, Governance, and Process for the Current Initiative;

Includes 15 minute discussion period

 

Moderator

9

11:15 – 11:45

Ross Filice, M.D.
Medical Officer
Division of Medical Imaging Products
CDER/FDA

Daniel C. Sullivan, M.D.
Professor & Vice Chair, Research
Department of Radiology
Duke University Medical Center

Image and Annotation Repository for Research, Regulation, and Drug Development

 

Moderator

10

11:45 a.m. – 12:15 p.m.

GET LUNCH AND RETURN FOR WORKING LUNCH

 

11

12:15 – 1:15 p.m.

Karen Hicks
Brian McCourt
Jimmy Tcheng
Bob Hendel
Meredith Nahm

Ground Rules
Data Elements Examples
Process Rules
Discussion

12

1:15 – 2:30 p.m.

Break-Out Groups

Tony Fuisz, M.D.
(Team Leader)
Director, Cardiac MRI
Washington Hospital Center

 

Robert C. Hendel, M.D.
(Team Leader)
Chairman, ACC/AHA Task Force on Data Standards

 

Leslee Shaw, Ph.D.
(Team Leader)
President, American Society of Nuclear Cardiology
Professor of Medicine
Co-Director, Emory Clinical CV Research Institute
Emory University School of Medicine

and

John P. Reilly, M.D.
(Team Leader)
Society for Cardiovascular Angiography and Interventions
Ochsner Clinic Foundation
New Orleans, LA

 

Neil J. Weissman, M.D.
(Team Leader)
President, MedStar Health
Research Institute
Director, Cardiovascular Core Labs
Professor of Medicine,
Georgetown University

 

Pamela Woodard, M.D., FACR (ACR/AHA/NASCI)
(Team Leader)
Mallinckrodt Institute of Radiology
Saint Louis, MO

 

Ross Filice, M.D. and
Lucie Yang, M.D.
(Team Leaders)
Division of Medical Imaging Products
FDA

Data Elements

  • Group 1:  Cardiac and chamber size and shape (SCMR)

 

 

  • Group 2:  Ventricular and atrial systolic and diastolic function (ACC/AHA)

 

 

  • Group 3:  Myocardial perfusion and metabolism; coronaries; stress (ASNC, SCAI)

 

 

 

 

 

 

 

  • Group 4:  Valvular structure and function ASE)

 

 

 

 

  • Group 5:  Pericardium and great vessels (ACR/AHA/NASCI)

 

Imaging Warehouse

  • Standards (Images and Annotations)
  • Infrastructure Support
  • Utility

13

2:30 – 4:30 p.m.

Break-Out Groups Report Back

 

Pamela S. Douglas, M.D.

(Approximately 15 minutes/group plus Q&A)

Moderator

14

4:30 – 5:00 p.m.

Pamela S. Douglas, M.D.

Summary and Next Steps