Observational Dutch Young Symptomatic StrokE studY (ODYSSEY): study rationale and protocol of a multicentre prospective cohort study

Renate M Arntz, Mayte E van Alebeek, Nathalie E Synhaeve, Paul J Brouwers, Gert W van Dijk, Rob A Gons, Tom den Heijer, Paul L M de Kort, Karlijn F de Laat, Anouk G van Norden, Sarah E Vermeer, Maureen J van der Vlugt, Roy P C Kessels, Ewoud J van Dijk, Frank-Erik de Leeuw, Renate M Arntz, Mayte E van Alebeek, Nathalie E Synhaeve, Paul J Brouwers, Gert W van Dijk, Rob A Gons, Tom den Heijer, Paul L M de Kort, Karlijn F de Laat, Anouk G van Norden, Sarah E Vermeer, Maureen J van der Vlugt, Roy P C Kessels, Ewoud J van Dijk, Frank-Erik de Leeuw

Abstract

Background: The proportion of strokes occurring in younger adults has been rising over the past decade. Due to the far longer life expectancy in the young, stroke in this group has an even larger socio-economic impact. However, information on etiology and prognosis remains scarce.

Methods/design: ODYSSEY is a multicentre prospective cohort study on the prognosis and risk factors of patients with a first-ever TIA, ischemic stroke or intracerebral hemorrhage aged 18 to 49 years. Our aim is to include 1500 patients. Primary outcome will be all cause mortality and risk of recurrent vascular events. Secondary outcome will be the risk of post-stroke epilepsy and cognitive impairment. Patients will complete structured questionnaires on outcome measures and risk factors. Both well-documented and less well-documented risk factors and potentially acute trigger factors will be investigated. Patients will be followed every 6 months for at least 3 years. In addition, an extensive neuropsychological assessment will be administered both at baseline and 1 year after the stroke/TIA. Furthermore we will include 250 stroke-free controls, who will complete baseline assessment and one neuropsychological assessment.

Discussion: ODYSSEY is designed to prospectively determine prognosis after a young stroke and get more insight into etiology of patients with a TIA, ischemic stroke and intracerebral hemorrhage in patients aged 18 to 49 years old in a large sample size.

Figures

Figure 1
Figure 1
Study design.

References

    1. Kissela BM, Khoury JC, Alwell K, Moomaw CJ, Woo D, Adeoye O, Flaherty ML, Khatri P, Ferioli S, De Los Rios La Rosa F, Broderick JP, Kleindorfer DO. Age at stroke: temporal trends in stroke incidence in a large, biracial population. Neurology. 2012;79(17):1781–1787. doi: 10.1212/WNL.0b013e318270401d.
    1. Nedeltchev K, der Maur TA, Georgiadis D, Arnold M, Caso V, Mattle HP, Schroth G, Remonda L, Sturzenegger M, Fischer U, Baumgartner RW. Ischaemic stroke in young adults: predictors of outcome and recurrence. J Neurol Neurosurg Psychiatry. 2005;76(2):191–195. doi: 10.1136/jnnp.2004.040543.
    1. Rutten-Jacobs LC, Arntz RM, Maaijwee NA, Schoonderwaldt HC, Dorresteijn LD, van Dijk EJ, de Leeuw FE. Long-term mortality after stroke among adults aged 18 to 50 years. JAMA. 2013;309(11):1136–1144. doi: 10.1001/jama.2013.842.
    1. Arntz R, Rutten-Jacobs L, Maaijwee N, Schoonderwaldt H, Dorresteijn L, van Dijk E, de Leeuw FE. Post-stroke epilepsy in young adults: a long-term follow-up study. PLoS One. 2013;8(2):e55498. doi: 10.1371/journal.pone.0055498.
    1. Schaapsmeerders P, Maaijwee NA, van Dijk EJ, Rutten-Jacobs LC, Arntz RM, Schoonderwaldt HC, Dorresteijn LD, Kessels RP, De Leeuw FE. Long-Term Cognitive Impairment After First-Ever Ischemic Stroke in Young Adults. Stroke; a j cereb circ. 2013.
    1. Fens M, van Heugten CM, Beusmans GH, Limburg M, Haeren R, Kaemingk A, Metsemakers JF. Not as transient: patients with transient ischaemic attack or minor stroke experience cognitive and communication problems; an exploratory study. Eur J Gen Pract. 2012.
    1. Pendlebury ST, Wadling S, Silver LE, Mehta Z, Rothwell PM. Transient cognitive impairment in TIA and minor stroke. Stroke; a j cereb circ. 2011;42(11):3116–3121. doi: 10.1161/STROKEAHA.111.621490.
    1. Luijendijk HJ, Stricker BH, Wieberdink RG, Koudstaal PJ, Hofman A, Breteler MM, Tiemeier H. Transient ischemic attack and incident depression. Stroke; a j cereb circ. 2011;42(7):1857–1861. doi: 10.1161/STROKEAHA.110.604405.
    1. George MG, Tong X, Kuklina EV, Labarthe DR. Trends in stroke hospitalizations and associated risk factors among children and young adults, 1995–2008. Ann Neurol. 2011;70(5):713–721. doi: 10.1002/ana.22539.
    1. Kittner SJ, Singhal AB. Premature atherosclerosis: A major contributor to early-onset ischemic stroke. Neurology. 2013;80(14):1272–1273. doi: 10.1212/WNL.0b013e31828ab3a4.
    1. De Los Rios F, Kleindorfer DO, Khoury J, Broderick JP, Moomaw CJ, Adeoye O, Flaherty ML, Khatri P, Woo D, Alwell K, Eilerman J, Ferioli S, Kissela BM. Trends in substance abuse preceding stroke among young adults: a population-based study. Stroke; a j cereb circ. 2012;43(12):3179–3183. doi: 10.1161/STROKEAHA.112.667808.
    1. Ferro JM, Massaro AR, Mas JL. Aetiological diagnosis of ischaemic stroke in young adults. Lancet Neurol. 2010;9(11):1085–1096. doi: 10.1016/S1474-4422(10)70251-9.
    1. Koton S, Tanne D, Bornstein NM, Green MS. Triggering risk factors for ischemic stroke: a case-crossover study. Neurology. 2004;63(11):2006–2010. doi: 10.1212/01.WNL.0000145842.25520.A2.
    1. Vlak MH, Rinkel GJ, Greebe P, van der Bom JG, Algra A. Trigger factors and their attributable risk for rupture of intracranial aneurysms: a case-crossover study. Stroke; a j cereb circ. 2011;42(7):1878–1882. doi: 10.1161/STROKEAHA.110.606558.
    1. Meschia JF, Lojacono MA, Miller MJ, Brott TG, Atkinson EJ, O’Brien PC. Reliability of the questionnaire for verifying stroke-free status. Cerebrovasc Dis (Basel, Switz) 2004;17(2–3):218–223.
    1. Verhage F. Intelligentie en leeftijd bij volwassenen en bejaarden [English: Intelligence and age in adults] Assen: Van Gorcum; 1964.
    1. Goldstein LB, Adams R, Alberts MJ, Appel LJ, Brass LM, Bushnell CD, Culebras A, DeGraba TJ, Gorelick PB, Guyton JR, Hart RG, Howard G, Kelly-Hayes M, Nixon JV, Sacco RL. Primary prevention of ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council: cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2006;113(24):e873–e923.
    1. Mittleman MA, Maclure M, Tofler GH, Sherwood JB, Goldberg RJ, Muller JE. Triggering of acute myocardial infarction by heavy physical exertion. Protection against triggering by regular exertion. Determinants of Myocardial Infarction Onset Study Investigators. N Engl J Med. 1993;329(23):1677–1683. doi: 10.1056/NEJM199312023292301.
    1. Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991;133(2):144–153.
    1. Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54(6):1063–1070.
    1. Bamford J, Sandercock P, Dennis M, Burn J, Warlow C. Classification and natural history of clinically identifiable subtypes of cerebral infarction. Lancet. 1991;337(8756):1521–1526. doi: 10.1016/0140-6736(91)93206-O.
    1. Mittleman MA, Maclure M, Sherwood JB, Mulry RP, Tofler GH, Jacobs SC, Friedman R, Benson H, Muller JE. Triggering of Acute Myocardial-Infarction Onset by Episodes of Anger. Circulation. 1995;92(7):1720–1725. doi: 10.1161/01.CIR.92.7.1720.
    1. Weuve J, Kang JH, Manson JE, Breteler MM, Ware JH, Grodstein F. Physical activity, including walking, and cognitive function in older women. JAMA. 2004;292(12):1454–1461. doi: 10.1001/jama.292.12.1454.
    1. Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, Rorick M, Moomaw C, Walker M. Measurements of acute cerebral infarction: a clinical examination scale. Stroke; a j cereb circ. 1989;20(7):864–870. doi: 10.1161/01.STR.20.7.864.
    1. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke; a j cereb circ. 1988;19(5):604–607. doi: 10.1161/01.STR.19.5.604.
    1. Bousser MG, Amarenco P, Chamorro A, Fisher M, Ford I, Fox K, Hennerici MG, Mattle HP, Rothwell PM. Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: The prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study. Cerebrovasc Dis (Basel, Switz) 2009;27(5):509–518. doi: 10.1159/000212671.
    1. Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005;58(5):688–697. doi: 10.1002/ana.20617.
    1. Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Hennerici MG. New approach to stroke subtyping: the A-S-C-O (phenotypic) classification of stroke. Cerebrovasc Dis (Basel, Switz) 2009;27(5):502–508. doi: 10.1159/000210433.
    1. Rutten-Jacobs LC, Maaijwee NA, Arntz RM, Schoonderwaldt HC, Dorresteijn LD, van der Vlugt MJ, van Dijk EJ, de Leeuw FE. Long-term risk of recurrent vascular events after young stroke: The FUTURE study. Ann Neurol. 2013;74(4):592–601. doi: 10.1002/ana.23953.
    1. Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke; a j cereb circ. 1996;27(8):1304–1305. doi: 10.1161/01.STR.27.8.1304.
    1. Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61–63. doi: 10.3109/09638288809164103.
    1. Elias P. Occupational Classification (ISCO-88): Concepts, Methods, Reliability, Validity and Cross-National Comparability. 20. OECD Publishing; 1997.
    1. de Groot JC, de Leeuw FE, Oudkerk M, van Gijn J, Hofman A, Jolles J, Breteler MM. Cerebral white matter lesions and cognitive function: The Rotterdam Scan Study. Ann Neurol. 2000;47(2):145–151. doi: 10.1002/1531-8249(200002)47:2<145::AID-ANA3>;2-P.
    1. Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998;351(9106):857–861. doi: 10.1016/S0140-6736(97)07382-0.
    1. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. Journal of psychiatric research. 1975;12(3):189–198. doi: 10.1016/0022-3956(75)90026-6.
    1. Van der Elst W, van Boxtel MP, van Breukelen GJ, Jolles J. Rey’s verbal learning test: normative data for 1855 healthy participants aged 24–81 years and the influence of age, sex, education, and mode of presentation. J Int Neuropsychol Soc. 2005;11(3):290–302.
    1. Van der Elst W, Van Boxtel MP, Van Breukelen GJ, Jolles J. The Stroop color-word test: influence of age, sex, and education; and normative data for a large sample across the adult age range. Assessment. 2006;13(1):62–79. doi: 10.1177/1073191105283427.
    1. Wechsler D. The Psychometric Tradition - Developing the Wechsler Adult Intelligence Scale. Contemp Educ Psychol. 1981;6(2):82–85. doi: 10.1016/0361-476X(81)90035-7.
    1. Osterrieth P. Le test de copie d’une figure complexe: Contribution a l’ étude de la perception et de la mémoire. Arch de Psychol. 1944;30:206–353.
    1. van den Berg E, Nys GM, Brands AM, Ruis C, van Zandvoort MJ, Kessels RP. The Brixton Spatial Anticipation Test as a test for executive function: validity in patient groups and norms for older adults. J Int Neuropsychol Soc. 2009;15(5):695–703. doi: 10.1017/S1355617709990269.
    1. Wilson B, Cockburn J, Halligan P. Development of a behavioral test of visuospatial neglect. Arch Phys Med Rehabil. 1987;68(2):98–102.
    1. Van Dongen HRvH F, Verhey-Stol FW, Luteijn F. Investigation of aphasia by means of the token test: Several psychometric characteristics and an appraisal of an abbreviated form. Ned Tijdschr Psychol. 1974;28(9):3–647.
    1. Wechsler Adult Intelligence Scale—Fourth Edition (WAIS–IV) [ ]
    1. Sternberg S. Memory-scanning: mental processes revealed by reaction-time experiments. Am Sci. 1969;57(4):421–457.
    1. Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982;21(Pt 1):1–16.
    1. Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989;19(4):1015–1022. doi: 10.1017/S0033291700005742.
    1. de Groot JC, de Leeuw FE, Oudkerk M, Hofman A, Jolles J, Breteler MM. Cerebral white matter lesions and depressive symptoms in elderly adults. Arch Gen Psychiatry. 2000;57(11):1071–1076. doi: 10.1001/archpsyc.57.11.1071.
    1. Williams JB, Spitzer RL. Research diagnostic criteria and DSM-III: an annotated comparison. Arch Gen Psychiatry. 1982;39(11):1283–1289. doi: 10.1001/archpsyc.1982.04290110039007.
    1. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33. quiz 34–57.
    1. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9(3):179–186.
    1. Vercoulen JH, Swanink CM, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G. Dimensional assessment of chronic fatigue syndrome. J Psychosom Res. 1994;38(5):383–392. doi: 10.1016/0022-3999(94)90099-X.
    1. EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16(3):199–208.
    1. Duncan PW, Bode RK, Min Lai S, Perera S. Rasch analysis of a new stroke-specific outcome scale: The Stroke Impact Scale. Arch Phys Med Rehabil. 2003;84(7):950–963. doi: 10.1016/S0003-9993(03)00035-2.
    1. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW. Joint E.S.C.A.A.H.A.W.H.F.T.F.f.t.R.o.M.I. Universal definition of myocardial infarction. Circulation. 2007;116(22):2634–2653. doi: 10.1161/CIRCULATIONAHA.107.187397.
    1. Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, Cross JH, van Emde BW, Engel J, French J, Glauser TA, Mathern GW, Moshe SL, Nordli D, Plouin P, Scheffer IE. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005–2009. Epilepsia. 2010;51(4):676–685. doi: 10.1111/j.1528-1167.2010.02522.x.
    1. Fisher RS, van Emde BW, Blume W, Elger C, Genton P, Lee P, Engel J Jr. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE) Epilepsia. 2005;46(4):470–472. doi: 10.1111/j.0013-9580.2005.66104.x.
    1. Gray RJ. A Class of K-Sample Tests for Comparing the Cumulative Incidence of a Competing Risk. Ann Stat. 1988;16(3):1141–1154. doi: 10.1214/aos/1176350951.
    1. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94(446):496–509. doi: 10.1080/01621459.1999.10474144.
    1. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. WMJ : official publication of the State Med Soc Wis. 1998;97(9):20–21. 24–25, 27–37.
    1. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med j Br Diabet Assoc. 1998;15(7):539–553. doi: 10.1002/(SICI)1096-9136(199807)15:7<539::AID-DIA668>;2-S.
    1. American Diabetes A. Standards of medical care in diabetes–2012. Diabetes care. 2012;35(Suppl 1):S11–S63.
    1. Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Struijker Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M. 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) Eur Heart J. 2007;28(12):1462–1536.
    1. Whitworth JA. World Health Organization ISoHWG: 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003;21(11):1983–1992.
    1. Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version) Cephalalgia. 2013;33(9):629–808.

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