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Making Heart Attack
Making Heart Attack
History©
Sheldon Adelson SHAPE Trial
Proposal
The Association for Eradication of Heart Attack (www.AEHA.org)The Association for Era...
Goal
Compare SHAPE v.s. Status Quo in
Reducing Cardiovascular Mortality and
Morbidity
The Sheldon Adelson SHAPE Trial
Study Design
Randomized trial with three arms:
- SHAPE Guidelines
- NCEP Guidelines
- Traditional practice (stress testing...
Study Design
Sample size:
15,000 total
5,000 in each arm matched with age,
sex, and ethnicity
Follow up: 10 years
The Shel...
• 15,000 persons followed for 10 years (6 clinic visits at $250 per visit,
plus $500 per patient for enrollment)
$30M
• Op...
Goals
A) Establish AEHA (Association for the Eradication of
Heart Attack) as the global leader of a revolutionary
movement...
Outline of the Projects
A) AEHA:
• Public education and fundraising (SHAPE, SHAPE-a-
thon, and the Vaccine Initiative)
• P...
Budget
• The proposal is based on a 50 million
dollar budget over 10 years (Phase I to
Phase V).
• Sources of funds: The A...
Budget
• The first 2 years --Phase I: including
discovery, organization, and one year
funded research for 3 institutions i...
Budget for Phase I
• AVPRI 3 millions ?
– New CCS score
– Molecular Imaging?
• AEHA 2 millions ?
– SHAPE and Vaccine Task ...
Budget for Phase I
• AVPRI 3 millions ?
– New CCS score
– Molecular Imaging?
Setting
A) AEHA and AVPRI completely non-profit and
educational. Both will be tied from organizational stand
point (board ...
Setting
B) AVPRI can be a for-profit research institute (if Adelson
wants his money back upon the success of the
institute...
Heart attack is NOT
the world’s number
one problem,
extreme poverty
is.
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
“50,000 per day die of
infectious diseases which
could almost all be cured or
prevented at a cost which
is sometimes no mo...
Much Kudus to Bono and the One Campaign
Extreme Poverty Is a Shame to the World
The AEHA 2005 VP SummitThe AEHA 2005 VP Su...
After extreme poverty and
associated infectious diseases,
eradication of heart attack
can be the most rewarding
opportunit...
How the World Dies Today?
YLLs: Yearsof LifeLost
Atherosclerotic
Diseases
The AEHA 2005 VP SummitThe AEHA 2005 VP SummitWo...
Worldwide Causes of Death Source: WHO
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
> 15 Million Heart Attacks Each Year
Source:
World
Heart
Federation
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
0
5
10
15
20
25
30
1990 2020
MillionsofDeaths
fromCardiovascularCauses
Western countries
Non-Western (developing)
countrie...
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
More thanMore than
half causedhalf caused
by a suddenby a sudden
heart attackheart attack
inin healthy-healthy-
lookingloo...
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
Epidemic
of Heart
Failure
Global Epidemic of Diabetes
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
Epidemic of Obesity & Diabetes in the
U.S.
1990/19911990/1991 20002000
ejt 0901–120
Mokdad et al., JAMAMokdad et al., JAMA...
Global Atherosclerosis;
A Bigger Threat than
Global Warming!
The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
•Heart attack is not equal
to heart disease, and is
not equal to
atherosclerosis either.
It is the attack part of
coronary...
Atherosclerosis Test
Negative Positive
No Risk Factors + Risk Factors
Step 1
Test for
Presence of the
Disease
Step 2
Strat...
Atherosclerosis Test
Very Low Risk
3
Negative Test
• CCS =0
• CIMT<50th
percentile
Lower
Risk
Moderate
Risk
Positive Test
...
Heart Attack Eradication History Makers
Faculty of the Past 9 VP Symposia and the SHAPE Task Force
Lets Hope the World Will Do First Thing First!
SHAPE
Get in SHAPE!
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  1. 1. Making Heart Attack Making Heart Attack History©
  2. 2. 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
  3. 3. Goal Compare SHAPE v.s. Status Quo in Reducing Cardiovascular Mortality and Morbidity The Sheldon Adelson SHAPE Trial
  4. 4. 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
  5. 5. 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
  6. 6. • 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
  7. 7. 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.
  8. 8. 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)
  9. 9. 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.
  10. 10. 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.
  11. 11. 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?
  12. 12. Budget for Phase I • AVPRI 3 millions ? – New CCS score – Molecular Imaging?
  13. 13. 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
  14. 14. 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.
  15. 15. Heart attack is NOT the world’s number one problem, extreme poverty is. The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  16. 16. “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
  17. 17. 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
  18. 18. 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
  19. 19. How the World Dies Today? YLLs: Yearsof LifeLost Atherosclerotic Diseases The AEHA 2005 VP SummitThe AEHA 2005 VP SummitWorld Health Organization
  20. 20. Worldwide Causes of Death Source: WHO The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  21. 21. > 15 Million Heart Attacks Each Year Source: World Heart Federation The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  22. 22. 0 5 10 15 20 25 30 1990 2020 MillionsofDeaths fromCardiovascularCauses Western countries Non-Western (developing) countries 5 million DEATHS FROM CARDIOVASCULAR CAUSES WORLDWIDE KS Reddy. NEJM 2004; 350:2438 9 million 19 million 6 million Over 2/3 of the global burden of heart attack and stroke is on poor countries. ~15m today >25m tomorrow The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  23. 23. The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  24. 24. 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
  25. 25. The AEHA 2005 VP SummitThe AEHA 2005 VP Summit Epidemic of Heart Failure
  26. 26. Global Epidemic of Diabetes The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  27. 27. 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
  28. 28. Global Atherosclerosis; A Bigger Threat than Global Warming! The AEHA 2005 VP SummitThe AEHA 2005 VP Summit
  29. 29. •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!
  30. 30. 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
  31. 31. 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
  32. 32. Heart Attack Eradication History Makers Faculty of the Past 9 VP Symposia and the SHAPE Task Force
  33. 33. Lets Hope the World Will Do First Thing First!
  34. 34. SHAPE
  35. 35. Get in SHAPE!

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