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Informing Strategies for Stroke Prevention Martin O’Donnell MB PhD MRCPI HRB Conference, Feb 26 2015 Director, HRB-Clinical Research Facility, NUI Galway.

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Presentation on theme: "Informing Strategies for Stroke Prevention Martin O’Donnell MB PhD MRCPI HRB Conference, Feb 26 2015 Director, HRB-Clinical Research Facility, NUI Galway."— Presentation transcript:

1 Informing Strategies for Stroke Prevention Martin O’Donnell MB PhD MRCPI HRB Conference, Feb Director, HRB-Clinical Research Facility, NUI Galway and Saolta Associate Professor, Translational Medicine, NUI Galway

2 Disclosures Principal Investigator INTERSTROKE (McMaster University, S Yusuf) (CIHR, CSN, ERC, HSFC) SLEPT trial (HRB) STICK trial (HRB) COSIP (ERC) Steering Committee EMBRACE trial AVERROES trial (Apixaban) COMPASS trial (Rivaroxaban) ESUS-Navigate (Rivaroxaban) Global Burden of Disease (Stroke Committee) Honoraria (BMS, Pfizer, BI and Sanofi Aventis)

3 O VERVIEW Importance of stroke INTERSTROKE study Salt intake and Stroke (and CVD) Highlight the required infrastructure/resources to complete clinical research programme Comments on evolution of Stroke research in Ireland

4 Global Burden of Stroke Leading cause of death and a leading cause of disability (85% occur in LMICs) Modifiable Risk Factors for Stroke INTERHEART 90% of PAR due to 9 potentially modifiable risk factors Yusuf et al INTERHEART Lancet 2001 Feigin et al Global Burden of Disease Lancet 2014

5 G LOBAL B URDEN OF S TROKE Feigin et al Lancet 2014 Age –adjusted per 100,000 patients years

6 INTERSTROKE (F ULL -S CALE S TUDY ) International standardized case-control study (Coordinated: PHRI, McMaster University, Canada) Shared methodology with INTERHEART 32 countries Mar 07-Aug 14 (n=26,508) N America/Europe: Australia, Canada, Croatia, Denmark, Germany, Ireland, Poland, Russia, Turkey, UK S America: Argentina, Brazil, Chile, Colombia, Ecuador, Peru Asia: China, India, Pakistan, Philippines, Malaysia, Thailand Africa: Mozambique, Nigeria, South Africa, Sudan, Uganda Middle East: Iran, Kuwait, Saudi Arabia, UEA Case: First stroke admitted within 5 days of symptom onset Proxy respondents for patients unable to complete Qs Control: No history of stroke (Matched for age and gender) Community and hospital-based controls

7 INTERSTROKE- O BJECTIVES Informing strategies for stroke prevention, globally and within regions Determine estimates of strength of association between vascular risk factors and stroke All stroke (global) Within stroke subtypes Within risk factors Determine regional variations in the importance of risk factors for stroke Importance of regional variations in developing prevention programs Determine the importance of emerging risk factors, particularly the role of genetics

8 INTERSTROKE (P HASE I: 6,000 FROM 22 C OUNTRIES ) P OPULATION A TTRIBUTABLE R ISK (A LL S TROKE ) 10 R ISK F ACTORS A SSOCIATED WITH 90% OF R ISK (A LL S TROKE ) O’Donnell et al INTERSTROKE Lancet 2010

9 PAR FOR A LL R ISK F ACTORS FOR A LL S TROKE B Y R EGION RegionPAR99% CI Western Europe Eastern/central Europe Middle east Africa South Asia* China South East Asia South America North America/Australia * Excluding apolipoproteins

10 B Y R EGION (I SCHEMIC S TROKE ) INTERSTROKE S TUDY 71% OF C ARDIAC C AUSES N=11,124 PATIENTS WITH STROKE IN 30 C OUNTRIES INTERSTROKE Lancet 2010, with unpublished data Kelly P et al Stroke 2012 Hannon Stroke 2013 N ORTH D UBLIN : 31.3%

11 Challenging Existing Recommendations

12 WHO Guideline: Sodium Intake < 2g/day Mozaffarin et al GBD NEJM 2014 INTERSALT BMJ 1988 O’Donnell et al JAMA 2011 O’Donnell et al NEJM 2014 < 3g/day Graudal et al AJH 2014 Systolic BP CV Events

13 Clarifying Optimal Sodium Intake in Populations

14 Epidemiology INTERSTROKE (N=27,204) PURE Cohort (N=101,975) ≈ 10,000 events 17 Countries Fasting urines Death, MI, Stroke Heart Failure 32 Countries Fasting and Random Urines Stroke (Subtypes) Who is at risk from high and low sodium intake? Does optimal intake vary by population? How important are other dietary factors? Sodium intake and other vascular-related outcomes

15 Genetics INTERSTROKE (n≈ 5,000) 17 Countries Fasting urines Death, MI, Stroke Heart Failure SNPs associated with: Blood pressure Renal Sodium Transportation RAAS Uromodulin Salt sensitivity

16 Effect of Sustained Low Sodium Intake On Cardiorenal Biomarkers Experimental (Randomised Controlled Trial) Outcomes CV/Renal Biomarkers (e.g. PRA, Aldosterone) 24-ABPM Phase IIb (n=286) Funded by HRB

17 Effect of ‘Evening Bolus’ versus Basal Pattern on 24-Hr ABPM Experimental (Randomised Controlled Trial) Primary Outcome 24-Hour ABPM Cross-over Trial (n=38) 4 X 2 Week Periods

18 Informing Novel Targets

19 Effect of Sleep Behaviour Intervention on Blood Pressure and CV Biomarkers SLEPT Trial 24-ABPM CV Biomarkers Phase IIb McGrath et al Trials 2014 Funded by HRB

20 Ireland, a Research Leader in Stroke: What is Required?

21 Collaborations International (PHRI, McMaster) National HRB Institutions/Other North Dublin Stroke Study RCTs (ESCAPE) HRB-Stroke Trials Network Prof Peter Kelly Prof Joe Harbison Prof David Williams Prof Des Kelly Dr Ronain Collins Research Studies Education/Training Funding Expertise Industry

22 Collaborations International (PHRI, McMaster) National HRB Institutions/Other North Dublin Stroke Study RCTs (ESCAPE) HRB-Stroke Trials Network Prof Peter Kelly Prof Joe Harbison Prof David Williams Prof Des Kelly Dr Ronain Collins Research Studies Education/Training Funding Expertise Industry HRB-CCRC

23 HRB- Clinical Research Facility-Galway Clinical Research Facilities Dublin (James’, Vincent’s, Beaumont, Mater) Cork Limerick HRB-Clinical Research Coordinating Centre Healthcare Hospital Networks General Practice/Community (Prof A Murphy) 2007: Capital funding for the HRB Clinical Projected commencement date is Sept 2013 Completion projected March 2015 Health Research Board Infrastructure

24 Multidisciplinary Expertise Expertise: Health Research Methodology Training (MSc in Clinical Research) Recruitment and retention of highly trained staff

25 HRB-Clinical Research Facility Galway Lisa Daly John Newell Caroline Kelly Michelle Kehoe Howard Foye Aideen O’Doherty Collette Kirwan Leona Moylan Elaine Faulkner Caroline Whiriskey Áine Keogh Emma Deenihan Alice Power Veronica McInerney Heather Kelly Linda Duane Laura McCormack Martin O’Donnell Mary Bourke Michael Faherty Alberto Alvarez Iglasias Patricia Gunning Sharon Conway Alice Power Gráinne MacNamara Máiread Waldron Emma Hawkins Clodagh Raleigh Patrick Hayes

26 Methodology and Biostatistics No, n=1s? Insufficient number Competing job opportunities Career path Research Enablement vs Researcher The science of how we do clinical research

27 S TROKE R ESEARCH AND HRB North Dublin Stroke Study (Prof P Kelly) TILDA study (Prof RA Kenny) Clinical Research Infrastructure Enabling competitive European Research Awards HRB-Stroke Clinical Trials Network Lead international clinical trials in stroke Next Generation of Stroke Researchers HRB-Research Fellowships Investigator support Early career support (key target) Thematic priority in Population Health Invest in Research Methodology and Biostatistics


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