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The SHAPE Trial Advisory Meeting
August 21-23, 2015


Los Angeles -Marina del Ray


Ritz-Carlton Hotel, Marina Vista Conference Room



Day 1:
Necessity, Feasibility, Design, Implementation, and Fundraising for a Longitudinal Outcome Study to Compare SHAPE Guidelines with the Status Quo

Day 2:
Public Healthcare Policies and Regulatory Initiatives, SHAPE Centers of Excellence




Sameer Bansilal, M.D.
Assistant Professor Medicine, Cardiology
Mount Sinai Hospital
New York, NY

Daniel Berman, M.D.
Director of Cardiac Imaging and of Nuclear Cardiology at Cedars-Sinai,
Los Angeles, CA

Mathew Budoff, M.D.
Professor of Medicine and Director of Preventive Cardiology, UCLA Harbor, Los Angeles, CA

Jeff Fine, Ph.D.
President/CEO of J&J Medical, LLC
SHAPE Centers of Excellence

Brenda Garrett-Superko, RN, CCA
CVD Nurse Researcher and
SHAPE Executive Board Member
Stanford, CA

Hattie Rees Hanley, MPP,
Director, Right Care Initiative,
UC Berkeley & DMHC
Berkeley, CA

Harvey Hecht, M.D.
Director of Cardiac CT Imaging Laboratory
Mount Sinai School of Medicine
New York, NY

Howard Hodis, M.D.
Director, Atherosclerosis Research Unit,
Division of Cardiovascular Medicine
Keck School of Medicine USC,
Los Angeles, CA

Sanjay Kaul, M.D.
Director of Cardiology Fellowship
Cedars-Sinai, UCLA
Los Angeles, CA

Dan Keeney, A.P.R.
Principal, KeenerPR
Director of SHAPE Public Relations
Dallas, TX

David Maron, M.D.
Professor and Director, Preventive Cardiology Stanford University School of Medicine, Stanford, CA

Michael McConnell, M.D.
Professor of Medicine (Cardiovascular) and, by courtesy, Electrical Engineering, Director, Cardiovascular Health Innovation; Stanford University, Stanford, CA

Jessica Mega, M.D., M.P.H.
Associate Professor at Harvard Medical School and Director, Google Baseline Study
Boston, MA

James Min, M.D.
Professor of Medicine and Radiology
Weill Cornell Medical College, Cornell University
New York, NY

Morteza Naghavi, M.D.
Founder and Executive Chairman of the SHAPE Task Force, President of MEDITEX
Houston, TX

Tasneem Naqvi, M.D., M.M.M.
Professor of Medicine and Director of Echocardiography, College of Medicine, May Clinic, Scottsdale, AZ

P.K. Shah, M.D.
Professor and Director, Atherosclerosis Research Center, Cedars-Sinai Medical Center, UCLA
Los Angeles, CA

Henrik Sillesen, M.D.
Professor and Head of Dept. of Vascular Surgery, Rigs Hospitalet, University of Copenhagen, Copenhagen, Denmark

Robert Superko, M.D.
Professor of Medicine and President at Cholesterol, Genetics, and Heart Disease Institute, Stanford, CA

JoAnne Zawitoski, J.D.
Chairwoman, SHAPE
Principal, Semmes, Bowen & Semmes LLC, Attorneys at Law, Baltimore, MD





Friday Aug 21, 2015:

Arrival in Los Angeles and Check-in @ Ritz-Carlton Marina del Rey


8:00 PM

Kick Off Dinner at Ritz-Carlton, Marina Vista Room



Morteza Naghavi, M.D.
Executive Chairman of SHAPE Task Force

JoAnne Zawitoski, J.D.
Chairwoman, SHAPE Board of Directors


Saturday August 22, 2015


6:30-7:30 AM



7:30-7:45 AM

Introduction and Review of the Agenda

Morteza Naghavi, M.D.

Moderators: PK Shah, M.D. and David Maron, M.D.


Session I   7:45-9:45 AM

Why do we need a SHAPE Outcome Trial? Isn’t the existing evidence enough?                                                                                   

Moderators comment followed by presentations on CAC and CIMT (the two SHAPE-approved testing modalities). The following will be addressed by presenters:

  • superior predictive value over risk factors and risk scores (including CRP and other non-traditional serum markers)

  • correlates with the progression and regression of the disease

  • increases compliance to therapy

  • and is cost effective

Coronary Artery Calcium Imaging
Presenters: Mathew Budoff, M.D. (Dan Berman, M.D. will present as needed)
30 Minutes
Carotid CIMT and Plaque Imaging
Presenters: Tasneem Naqvi, M.D. (Henrik Sillesen, M.D., and Howard Hodis, M.D. will present as needed)

30 Minutes


Where Do We Stand on Genetic, Proteomic, and Functional Testing?

Presenters: Robert Superko, M.D.Jessica Mega, M.D., Morteza Naghavi, M.D.                       

30 Minutes (10 minutes each)

30 Minutes Moderated Discussions. All attendees please prepare to comment.

9:45-10:00 AM



Session II  10:00 AM -12:00 PM


Why bother testing? Treat all at-risk population. (Unconditional Therapy) vs. (Testing + Therapy)

and discussions on Polypill in primary and secondary prevention.

Presenter: Sanjay Kaul, M.D.

30 minutes


Discussions on SHAPE II Guidelines – is it time to update? 3D Carotid and Polypill are not ready, what’s new?
-Discuss “de-escalation” based on zero CAC and no-plaque in carotids.

-Discuss Dr. PK Shah’s approach; starting with carotid ultrasound imaging, if found no plaque then

proceed with coronary calcium imaging.

60 Minutes Moderated Discussions. All attendees please prepare to comment.


12PM  WORKING LUNCH (Discussions continue during Lunch)


Session III 12:00 – 4:30 SHAPE Trial

12:00-2:00 PM


Brainstorming on the Design and Implementation of a SHAPE Trial


Review of Phil Greenland’s Proposal to NIH: Design of the Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) Trial
Presenter: Mathew Budoff, M.D.

15 Minutes


What can we learn from HRP / Bio-Image Study?

Presenter: Sameer Bansilal, M.D.

15 Minutes


What can we learn from the new mobile health studies?

(e-Heart of USCF and MyHeart Counts of Stanford particularly for rapid recruitment and cost reduction.

Presenter: Michael McConnell, M.D.

15 Minutes

What is Google Baseline Study and can we collaborate with Google?

Presenter: Jessica Mega, M.D.

15 Minutes


30 Minutes Discussions. All attendees please prepare to comment.


1:30-2:00 PM



2:00-2:30 PM

Skype presentation on SHAPE trial design by Jim Min from Cornell University


2:30-3:00 PM

David Maron discusses key questions:      


What is the study question?

Primary endpoint?

Selection criteria?

What is the intervention?

How many patients?

How long a period of follow-up?

Approximately how much will it cost?


60 Minutes Moderated Discussions. All attendees please prepare to comment.                    


4:00-4:30 PM





Session IV


Moderators: JoAnne Zawitoski, J.D. and Brenda Garrett-Superko, RN, CCA


4:30-6:30 PM

Part I -How to Fund the SHAPE Trial; Fundraising and Public Relations

Presenter: Daniel Keeney                       

  • A review of potential sources of funding

    • Philanthropic Donors

    • Charitable Organizations Offering Research Grants

    • Crowdfunding / Public Fundraising

ALS “The Ice Bucket Challenge”

  • SHAPE’s “The Up” Campaign (10 push-ups, sit-ups?)


Review successful public fundraising campaigns and brainstorm on funding based on milestones.


6:30 PM

Adjourn and Plan for Sunday Morning
Morteza Naghavi, M.D.



Sunday August 23, 2015

6:30-7:30 AM




David Maron, M.D. and Morteza Naghavi, M.D.


7:30 – 9:00 AM

Public Healthcare Policies (Challenges and Promises)

  • Lessons learned from Texas SHAPE Law (HB1290)

  • California Initiative presented by Hattie Hanley, MPP

  • Federal Initiative

    • Legislative – Obama Care

    • USPSTF Guidelines


9:00 – 10:00 AM

SHAPE Centers of Excellence

Presenter: Jeff Fine, Ph.D.

  • What exactly do we provide?

  • How do we measure success?

  • How can we enhance it?

  • What can you do to help?


10:00- 10:30 AM

Conclusions by Moderators


11:00  AM

Adjourn and Plans for AHA 2015 SHAPE Symposium

Morteza Naghavi, M.D.



Click to view photos from the event!
shapetrialadvisoryphotos (18).png
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