10. Sheldon Adelson SHAPE Trial
Proposal
The Association for Eradication of Heart Attack (www.AEHA.org)The Association for Eradication of Heart Attack (www.AEHA.org)
Quantum Leap in Preventive Cardiology
11.
12.
13. Goal
Compare SHAPE v.s. Status Quo in
Reducing Cardiovascular Mortality and
Morbidity
The Sheldon Adelson SHAPE Trial
14. Study Design
Randomized trial with three arms:
- SHAPE Guidelines
- NCEP Guidelines
- Traditional practice (stress testing)
Screen and treat asymptomatic at-risk
population (men 45-75y women 55-75y)
according to each of the above.
The Sheldon Adelson SHAPE Trial
15. Study Design
Sample size:
15,000 total
5,000 in each arm matched with age,
sex, and ethnicity
Follow up: 10 years
The Sheldon Adelson SHAPE Trial
16. • 15,000 persons followed for 10 years (6 clinic visits at $250 per visit,
plus $500 per patient for enrollment)
$30M
• Operations for 20 study sites at
$200K/year = $40M
The Sheldon Adelson SHAPE Trial
17. Goals
A) Establish AEHA (Association for the Eradication of
Heart Attack) as the global leader of a revolutionary
movement in the field of cardiology and public health
(beyond AHA and ACC) to lead the way for
eradicating heart attack.
B) Establish AVPRI (Adelson Vulnerable Patient
Research Institute) as the leading R&D institution in
developing new technologies and methods for
screening, detection, and treatment of the vulnerable
patient.
18. Outline of the Projects
A) AEHA:
• Public education and fundraising (SHAPE, SHAPE-a-
thon, and the Vaccine Initiative)
• Professional: ACPC (American College of Preventive
Cardiology), JPC (Journal of Preventive Cardiology), National
Guidelines and Task Forces (SHAPE, PolyPill, Vaccine),
B) AVPRI:
• Biomarker (serum markers and non-imaging monitoring tools)
• Imaging (non-contrast CT, VP Score, contrast enhanced plaque
characterization, and Molecular Imaging of )
• Immune modulation therapy (for rapid plaque stabilization)
19. Budget
• The proposal is based on a 50 million
dollar budget over 10 years (Phase I to
Phase V).
• Sources of funds: The Adelson Foundation
and matching funds from NIH, NSF, CV
industry, and other donors including public
fundraising.
• The Adelson Foundation will be named as
the first principal donor of AEHA, and the
sole name on AVPRI.
20. Budget
• The first 2 years --Phase I: including
discovery, organization, and one year
funded research for 3 institutions in
collaboration with AVPRI-- is budgeted at
$5 millions.
• During the Phase I, necessary data for
submitting NIH grants and obtaining
matching funds
• Given successful meeting of the Phase I
milestones at 18 months, a detailed budget
for Phase II-V will be submitted.
21. Budget for Phase I
• AVPRI 3 millions ?
– New CCS score
– Molecular Imaging?
• AEHA 2 millions ?
– SHAPE and Vaccine Task Force, Symposia,
Public Relations, Fundraising and SHAPE-a-
thon
– ACPC, and JPC Journal?
22. Budget for Phase I
• AVPRI 3 millions ?
– New CCS score
– Molecular Imaging?
23. Setting
A) AEHA and AVPRI completely non-profit and
educational. Both will be tied from organizational stand
point (board of directors etc). Fundraising foundation
arms will be the major organs of the organization and
donations will be the major source of income beside
conventions and educational products. Depending on
the success in fundraising both may offer grant
opportunities and in case of new inventions and
discoveries the organization will license out
technologies. In the far future depending on the level of
success it may open a venture arm to fund spin off start
ups that are totally focused on the mission of
eradicating heart attacks. Existing (but far less than
perfect) models for AEHA are ACS, AHA, and ADA,
and for ACPC are ACC and RSNA
24. Setting
B) AVPRI can be a for-profit research institute (if Adelson
wants his money back upon the success of the
institute) or a non-profit research institute. To succeed
quickly given the extremely competitive environment,
small budget, and so many other reasons, it needs to
be (or at least start) more like a virtual campus, building
projects predominantly based on collaborative multi-
center projects through various master agreements for
affiliation. It can act like a vehicle (an off shore
company) but strong management and great ideas. It
can license in technologies to complete its package
and it will be heavily involved in spinning off
technologies and incubating startups.
25.
26. Heart attack is NOT
the world’s number
one problem,
extreme poverty
is.
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
27. “50,000 per day die of
infectious diseases which
could almost all be cured or
prevented at a cost which
is sometimes no more than
$1 per person”
World Health Organization
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
Extreme Poverty Is a Shame to the World
28. Much Kudus to Bono and the One Campaign
Extreme Poverty Is a Shame to the World
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
29. After extreme poverty and
associated infectious diseases,
eradication of heart attack
can be the most rewarding
opportunity in the 21st
century
for saving productive life years
worldwide.
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
30. How the World Dies Today?
YLLs: Yearsof LifeLost
Atherosclerotic
Diseases
The AEHA 2005 VP SummitThe AEHA 2005 VP SummitWorld Health Organization
31. Worldwide Causes of Death Source: WHO
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
32. > 15 Million Heart Attacks Each Year
Source:
World
Heart
Federation
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
35. More thanMore than
half causedhalf caused
by a suddenby a sudden
heart attackheart attack
inin healthy-healthy-
lookinglooking
populationpopulation
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
36.
37. The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
Epidemic
of Heart
Failure
38. Global Epidemic of Diabetes
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
39. Epidemic of Obesity & Diabetes in the
U.S.
1990/19911990/1991 20002000
ejt 0901–120
Mokdad et al., JAMAMokdad et al., JAMA
286:1195–1200, 2001286:1195–1200, 2001 No DataNo Data < 4%< 4% 4%-6%4%-6% > 6%> 6%
No DataNo Data < 10%< 10% 10%-14%10%-14% 15%-19%15%-19% ≥≥ 20%20%
ObesityObesity
DiabetesDiabetes
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
41. •Heart attack is not equal
to heart disease, and is
not equal to
atherosclerosis either.
It is the attack part of
coronary heart disease
that is most devastating,
and the first focal point of
the AEHA movement.
Heart attack is the tip of
atherosclerosis problem.
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
Prevent Attack!
42.
43. Atherosclerosis Test
Negative Positive
No Risk Factors + Risk Factors
Step 1
Test for
Presence of the
Disease
Step 2
Stratify based on the
Severity of the Disease and
Presence of Risk Factors
Step 3
Treat based on
the Level of
Risk
Lower
Risk
Moderate
Risk
Moderately
High Risk
High
Risk
Very
High Risk
Apparently Healthy At-Risk Population
The 1st S.H.A.P.E. Guideline
Towards the National Screening for Heart Attack Prevention and Education (SHAPE) Program
Conceptual Flow Chart
<75th
Percentile
75th-90th
Percentile
≥90th
Percentile
44.
45. Atherosclerosis Test
Very Low Risk
3
Negative Test
• CCS =0
• CIMT<50th
percentile
Lower
Risk
Moderate
Risk
Positive Test
• CCS ≥1
• CIMT ≥50th
percentile or Carotid Plaque
Moderately
High Risk
High
Risk
Very
High Risk
No Risk Factors5 + Risk Factors • CCS <100 & <75th%
• CIMT <1mm & <75th%
& No Carotid Plaque
• Coronary Calcium Score (CCS)
or
• Carotid IMT (CIMT) & Carotid Plaque4
• CCS 100-399 or >75th%
• CIMT ≥1mm or >75th%
or <50% Stenotic Plaque
• CCS >100 & >90th%
or CCS ≥400
• ≥50% Stenotic Plaque6
IndividualizedIndividualizedIndividualized5-10 years5-10 yearsRe-test Interval
<70 mg/dl<100 mg/dl
<70 Optional
<130 mg/dl
<100 Optional
<130 mg/dl<160 mg/dlLDL
Target
All >75y receive unconditional treatment2
Apparently Healthy Population Men>45y Women>55y1
ExitExit
Myocardial
IschemiaTest
NoAngiography
Follow Existing
Guidelines
Yes
The 1st S.H.A.P.E. Guideline
Towards the National Screening for Heart Attack Prevention and Education (SHAPE) Program
Step 1
Step 2
Step 3
Optional
CRP>4mg
ABI<0.9
46.
47. Heart Attack Eradication History Makers
Faculty of the Past 9 VP Symposia and the SHAPE Task Force