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- The document proposes the Sheldon Adelson SHAPE Trial, a randomized controlled trial that would compare the SHAPE guidelines to existing guidelines in reducing cardiovascular mortality and morbidity. - The trial would involve screening and treating 15,000 asymptomatic at-risk individuals aged 45-75 according to the different guidelines over 10 years. - The proposal also outlines the establishment of the Association for Eradication of Heart Attack and the Adelson Vulnerable Patient Research Institute to lead efforts in preventing heart attacks through education, research, and developing new screening and treatment methods.
Ppt for adelson sketch
- 6. Making Heart Attack Making Heart Attack History©
- 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
- 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.
- 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
- 33. 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
- 34. 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
- 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
- 40. Global Atherosclerosis; A Bigger Threat than Global Warming! 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!
- 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
- 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
- 47. Heart Attack Eradication History Makers Faculty of the Past 9 VP Symposia and the SHAPE Task Force
- 48. Lets Hope the World Will Do First Thing First!
- 49. SHAPE
- 50. Get in SHAPE!