Apnea, Stroke and Incident Cardiovascular Events

NCT04399200 | Recruiting DMC

• 1 other identifier: 2019-A03085-52
• Study Type: observational
• Target: 1,620
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease. 1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort. Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) \> 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.

Conditions

Stroke; Sleep-disordered Breathing; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Fragmentation, Sleep

Keywords

Stroke; Sleep-disordered Breathing; Cardio-Vascular Events; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)

  Composite endpoint composed of cardiac or cerebrovascular events regrouping: death from cardiac of cerebrovascular cause, non fatal stroke (either ischemic or hemorrhagic), and non-fatal acute coronary disease

  1 year after SDB diagnosis

Secondary Outcomes (33)

• Prevalence of Major Adverse Cardiac or Cerebrovascular Events (MACCEs)

  5 years after SDB diagnosis

• Prevalence of secondary cardiac or cerebrovascular events

  5 years after SDB diagnosis

• Change in BMI from inclusion to 5 years

  at inclusion, and at each visit up to 5 years after SDB diagnosis

• Change in waist, neck, and abdominal circumferences, from inclusion visit to 5 years

  at inclusion, and at each visit up to 5 years after SDB diagnosis

• Change in NIHSS score from inclusion to 5 years

  at inclusion, and at each visit up to 5 years after SDB diagnosis

Study Arms (2)

Sleep-disordered breathing group

Sleep-disordered breathing (SDB) patients (AHI\>15/h, measured by polysomnography performed 3 months after stroke)

Device: Treatment according to standard care recommandation

Control group

Control patients with no SDB (AHI\<15/h, measured by polysomnography performed 3 months after stroke)

Interventions

Treatment according to standard care recommandation DEVICE

SDB treatment according to standard care recommandation: Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Device, Positionnal Therapy, Adaptive Servo-Ventilation (ASV), Non-Invasive Ventilation (NIV)

Sleep-disordered breathing group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the acute phase (\<72h) of a first stroke or initial/recurrent TIA, admitted in the stroke unit of the Grenoble Alpes University Hospital.

You may qualify if:

• Male or female, aged 18 to 85 years
• Admitted in the stroke unit no later than 72h after the onset of stroke symptoms:
• First stroke confirmed by computed tomography scan or magnetic resonance imaging, whatever the localization
• Initial or recurrent TIA, as defined by a brief and sudden neurological dysfunction for which an ischemic cause is presumed, with symptoms lasting less than 24 hours, and/or with no visible lesion on neuroimaging evaluation.
• Score on the Modified Ranking scale (mRS) ≤1 before stroke
• Signed informed consent by patient or his/her relative if not able
• Patient eligible to carotid endarterectomy (for ancillary study only)

You may not qualify if:

• Pregnant or breastfeeding women
• Past history of stroke
• Inability to follow rehabilitation procedure
• Patients with ongoing treatment for SDB
• Patients not affiliated to a French social and health insurance system or equivalent
• Prisoners or patients who require protection by the law

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

RECRUITING

Related Publications (50)

• GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

  PMID: 30871944 BACKGROUND

• Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. doi: 10.1016/j.jacc.2016.11.069.

  PMID: 28209226 BACKGROUND

• Hermann DM, Bassetti CL. Role of sleep-disordered breathing and sleep-wake disturbances for stroke and stroke recovery. Neurology. 2016 Sep 27;87(13):1407-16. doi: 10.1212/WNL.0000000000003037. Epub 2016 Aug 3.

  PMID: 27488603 BACKGROUND

• Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11.

  PMID: 30635478 BACKGROUND

• Lisabeth LD, Sanchez BN, Lim D, Chervin RD, Case E, Morgenstern LB, Tower S, Brown DL. Sleep-disordered breathing and poststroke outcomes. Ann Neurol. 2019 Aug;86(2):241-250. doi: 10.1002/ana.25515. Epub 2019 Jun 19.

  PMID: 31155749 BACKGROUND

• Brill AK, Horvath T, Seiler A, Camilo M, Haynes AG, Ott SR, Egger M, Bassetti CL. CPAP as treatment of sleep apnea after stroke: A meta-analysis of randomized trials. Neurology. 2018 Apr 3;90(14):e1222-e1230. doi: 10.1212/WNL.0000000000005262. Epub 2018 Mar 9.

  PMID: 29523641 BACKGROUND

• Amarenco P, Lavallee PC, Labreuche J, Albers GW, Bornstein NM, Canhao P, Caplan LR, Donnan GA, Ferro JM, Hennerici MG, Molina C, Rothwell PM, Sissani L, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wong LK; TIAregistry.org Investigators. One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke. N Engl J Med. 2016 Apr 21;374(16):1533-42. doi: 10.1056/NEJMoa1412981.

  PMID: 27096581 BACKGROUND

• Amarenco P, Lavallee PC, Monteiro Tavares L, Labreuche J, Albers GW, Abboud H, Anticoli S, Audebert H, Bornstein NM, Caplan LR, Correia M, Donnan GA, Ferro JM, Gongora-Rivera F, Heide W, Hennerici MG, Kelly PJ, Kral M, Lin HF, Molina C, Park JM, Purroy F, Rothwell PM, Segura T, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wang Y, Wong LKS; TIAregistry.org Investigators. Five-Year Risk of Stroke after TIA or Minor Ischemic Stroke. N Engl J Med. 2018 Jun 7;378(23):2182-2190. doi: 10.1056/NEJMoa1802712. Epub 2018 May 16.

  PMID: 29766771 BACKGROUND

• Wardlaw JM, Brazzelli M, Chappell FM, Miranda H, Shuler K, Sandercock PA, Dennis MS. ABCD2 score and secondary stroke prevention: meta-analysis and effect per 1,000 patients triaged. Neurology. 2015 Jul 28;85(4):373-80. doi: 10.1212/WNL.0000000000001780. Epub 2015 Jul 1.

  PMID: 26136519 BACKGROUND

• Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.

  PMID: 28626052 BACKGROUND

• Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjogren M, Wallin A, Ader H, Leys D, Pantoni L, Pasquier F, Erkinjuntti T, Scheltens P; European Task Force on Age-Related White Matter Changes. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001 Jun;32(6):1318-22. doi: 10.1161/01.str.32.6.1318.

  PMID: 11387493 BACKGROUND

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Cramer SC, Wolf SL, Adams HP Jr, Chen D, Dromerick AW, Dunning K, Ellerbe C, Grande A, Janis S, Lansberg MG, Lazar RM, Palesch YY, Richards L, Roth E, Savitz SI, Wechsler LR, Wintermark M, Broderick JP. Stroke Recovery and Rehabilitation Research: Issues, Opportunities, and the National Institutes of Health StrokeNet. Stroke. 2017 Mar;48(3):813-819. doi: 10.1161/STROKEAHA.116.015501. Epub 2017 Feb 7. No abstract available.

  PMID: 28174324 BACKGROUND

• Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.

  PMID: 24788967 BACKGROUND

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

• Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.

  PMID: 27188535 BACKGROUND

• Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.

  PMID: 23066376 BACKGROUND

• Levy P, Tamisier R, Minville C, Launois S, Pepin JL. Sleep apnoea syndrome in 2011: current concepts and future directions. Eur Respir Rev. 2011 Sep 1;20(121):134-46. doi: 10.1183/09059180.00003111. No abstract available.

  PMID: 21881142 BACKGROUND

• McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

  PMID: 27571048 BACKGROUND

• Alexiev F, Brill AK, Ott SR, Duss S, Schmidt M, Bassetti CL. Sleep-disordered breathing and stroke: chicken or egg? J Thorac Dis. 2018 Dec;10(Suppl 34):S4244-S4252. doi: 10.21037/jtd.2018.12.66.

  PMID: 30687540 BACKGROUND

• Loke YK, Brown JW, Kwok CS, Niruban A, Myint PK. Association of obstructive sleep apnea with risk of serious cardiovascular events: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):720-8. doi: 10.1161/CIRCOUTCOMES.111.964783. Epub 2012 Jul 24.

  PMID: 22828826 BACKGROUND

• Duss SB, Brill AK, Bargiotas P, Facchin L, Alexiev F, Manconi M, Bassetti CL. Sleep-Wake Disorders in Stroke-Increased Stroke Risk and Deteriorated Recovery? An Evaluation on the Necessity for Prevention and Treatment. Curr Neurol Neurosci Rep. 2018 Sep 7;18(10):72. doi: 10.1007/s11910-018-0879-6.

  PMID: 30194550 BACKGROUND

• Bassetti CL, Milanova M, Gugger M. Sleep-disordered breathing and acute ischemic stroke: diagnosis, risk factors, treatment, evolution, and long-term clinical outcome. Stroke. 2006 Apr;37(4):967-72. doi: 10.1161/01.STR.0000208215.49243.c3. Epub 2006 Mar 16.

  PMID: 16543515 BACKGROUND

• Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

  PMID: 16282178 BACKGROUND

• Sahlin C, Sandberg O, Gustafson Y, Bucht G, Carlberg B, Stenlund H, Franklin KA. Obstructive sleep apnea is a risk factor for death in patients with stroke: a 10-year follow-up. Arch Intern Med. 2008 Feb 11;168(3):297-301. doi: 10.1001/archinternmed.2007.70.

  PMID: 18268171 BACKGROUND

• Aaronson JA, van Bennekom CA, Hofman WF, van Bezeij T, van den Aardweg JG, Groet E, Kylstra WA, Schmand BA. The effect of obstructive sleep apnea and treatment with continuous positive airway pressure on stroke rehabilitation: rationale, design and methods of the TOROS study. BMC Neurol. 2014 Feb 25;14:36. doi: 10.1186/1471-2377-14-36.

  PMID: 24568360 BACKGROUND

• Kaneko Y, Hajek VE, Zivanovic V, Raboud J, Bradley TD. Relationship of sleep apnea to functional capacity and length of hospitalization following stroke. Sleep. 2003 May 1;26(3):293-7. doi: 10.1093/sleep/26.3.293.

  PMID: 12749548 BACKGROUND

• Duss SB, Seiler A, Schmidt MH, Pace M, Adamantidis A, Muri RM, Bassetti CL. The role of sleep in recovery following ischemic stroke: A review of human and animal data. Neurobiol Sleep Circadian Rhythms. 2016 Nov 29;2:94-105. doi: 10.1016/j.nbscr.2016.11.003. eCollection 2017 Jan.

  PMID: 31236498 BACKGROUND

• Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.

  PMID: 12855835 BACKGROUND

• Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.

  PMID: 11147987 BACKGROUND

• Kendzerska T, Wilton K, Bahar R, Ryan CM. Short- and long-term continuous positive airway pressure usage in the post-stroke population with obstructive sleep apnea. Sleep Breath. 2019 Dec;23(4):1233-1244. doi: 10.1007/s11325-019-01811-9. Epub 2019 Feb 28.

  PMID: 30820850 BACKGROUND

• Tsivgoulis G, Alexandrov AV, Katsanos AH, Barlinn K, Mikulik R, Lambadiari V, Bonakis A, Alexandrov AW. Noninvasive Ventilatory Correction in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis. Stroke. 2017 Aug;48(8):2285-2288. doi: 10.1161/STROKEAHA.117.017661. Epub 2017 Jun 8.

  PMID: 28596449 BACKGROUND

• Parra O, Sanchez-Armengol A, Capote F, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, Martinez-Null C, de la Pena M, Jimenez MC, Masa F, Casadon I, Alonso ML, Macarron JL. Efficacy of continuous positive airway pressure treatment on 5-year survival in patients with ischaemic stroke and obstructive sleep apnea: a randomized controlled trial. J Sleep Res. 2015 Feb;24(1):47-53. doi: 10.1111/jsr.12181. Epub 2014 Jul 21.

  PMID: 25040553 BACKGROUND

• Martinez-Garcia MA, Campos-Rodriguez F, Soler-Cataluna JJ, Catalan-Serra P, Roman-Sanchez P, Montserrat JM. Increased incidence of nonfatal cardiovascular events in stroke patients with sleep apnoea: effect of CPAP treatment. Eur Respir J. 2012 Apr;39(4):906-12. doi: 10.1183/09031936.00011311. Epub 2011 Sep 29.

  PMID: 21965227 BACKGROUND

• Barbe F, Duran-Cantolla J, Sanchez-de-la-Torre M, Martinez-Alonso M, Carmona C, Barcelo A, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, Diaz de Atauri J, Teran J, Mayos M, de la Pena M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

  PMID: 22618923 BACKGROUND

• Kim Y, Koo YS, Lee HY, Lee SY. Can Continuous Positive Airway Pressure Reduce the Risk of Stroke in Obstructive Sleep Apnea Patients? A Systematic Review and Meta-Analysis. PLoS One. 2016 Jan 5;11(1):e0146317. doi: 10.1371/journal.pone.0146317. eCollection 2016.

  PMID: 26731604 BACKGROUND

• Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.

  PMID: 7678184 BACKGROUND

• Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Hennerici MG. Classification of stroke subtypes. Cerebrovasc Dis. 2009;27(5):493-501. doi: 10.1159/000210432. Epub 2009 Apr 3.

  PMID: 19342825 BACKGROUND

• Naylor AR, Ricco JB, de Borst GJ, Debus S, de Haro J, Halliday A, Hamilton G, Kakisis J, Kakkos S, Lepidi S, Markus HS, McCabe DJ, Roy J, Sillesen H, van den Berg JC, Vermassen F, Esvs Guidelines Committee, Kolh P, Chakfe N, Hinchliffe RJ, Koncar I, Lindholt JS, Vega de Ceniga M, Verzini F, Esvs Guideline Reviewers, Archie J, Bellmunt S, Chaudhuri A, Koelemay M, Lindahl AK, Padberg F, Venermo M. Editor's Choice - Management of Atherosclerotic Carotid and Vertebral Artery Disease: 2017 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jan;55(1):3-81. doi: 10.1016/j.ejvs.2017.06.021. Epub 2017 Aug 26. No abstract available.

  PMID: 28851594 BACKGROUND

• Schulz R, Seeger W, Fegbeutel C, Husken H, Bodeker RH, Tillmanns H, Grebe M. Changes in extracranial arteries in obstructive sleep apnoea. Eur Respir J. 2005 Jan;25(1):69-74. doi: 10.1183/09031936.04.00030004.

  PMID: 15640325 BACKGROUND

• Ehrhardt J, Schwab M, Finn S, Guenther A, Schultze T, Witte OW, Rupprecht S. Sleep apnea and asymptomatic carotid stenosis: a complex interaction. Chest. 2015 Apr;147(4):1029-1036. doi: 10.1378/chest.14-1655.

  PMID: 25429400 BACKGROUND

• Suzuki M, Shimamoto K, Sekiguchi H, Harada T, Satoya N, Inoue Y, Yamaguchi K, Kawana M. Arousal index as a marker of carotid artery atherosclerosis in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Mar;23(1):87-94. doi: 10.1007/s11325-018-1664-0. Epub 2018 May 19.

  PMID: 29779142 BACKGROUND

• Eken SM, Jin H, Chernogubova E, Li Y, Simon N, Sun C, Korzunowicz G, Busch A, Backlund A, Osterholm C, Razuvaev A, Renne T, Eckstein HH, Pelisek J, Eriksson P, Gonzalez Diez M, Perisic Matic L, Schellinger IN, Raaz U, Leeper NJ, Hansson GK, Paulsson-Berne G, Hedin U, Maegdefessel L. MicroRNA-210 Enhances Fibrous Cap Stability in Advanced Atherosclerotic Lesions. Circ Res. 2017 Feb 17;120(4):633-644. doi: 10.1161/CIRCRESAHA.116.309318. Epub 2016 Nov 28.

  PMID: 27895035 BACKGROUND

• Wang LQ, Wang CL, Xu LN, Hua DF. The expression research of miR-210 in the elderly patients with COPD combined with ischemic stroke. Eur Rev Med Pharmacol Sci. 2016 Nov;20(22):4756-4760.

  PMID: 27906445 BACKGROUND

• Duncan PW, Lai SM, Bode RK, Perera S, DeRosa J. Stroke Impact Scale-16: A brief assessment of physical function. Neurology. 2003 Jan 28;60(2):291-6. doi: 10.1212/01.wnl.0000041493.65665.d6.

  PMID: 12552047 BACKGROUND

• Nadarajah M, Mazlan M, Abdul-Latif L, Goh HT. Test-retest reliability, internal consistency and concurrent validity of Fatigue Severity Scale in measuring post-stroke fatigue. Eur J Phys Rehabil Med. 2017 Oct;53(5):703-709. doi: 10.23736/S1973-9087.16.04388-4. Epub 2016 Oct 21.

  PMID: 27768012 BACKGROUND

• Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

  PMID: 11113214 BACKGROUND

• Flamand-Roze C, Falissard B, Roze E, Maintigneux L, Beziz J, Chacon A, Join-Lambert C, Adams D, Denier C. Validation of a new language screening tool for patients with acute stroke: the Language Screening Test (LAST). Stroke. 2011 May;42(5):1224-9. doi: 10.1161/STROKEAHA.110.609503. Epub 2011 Apr 12.

  PMID: 21487118 BACKGROUND

• Spitzer RL. More on pseudoscience in science and the case for psychiatric diagnosis. A critique of D.L. Rosenhan's "On Being Sane in Insane Places" and "The Contestual Nature of Psychiatric Diagnosis". Arch Gen Psychiatry. 1976 Apr;33(4):459-70. doi: 10.1001/archpsyc.1976.01770040029007.

  PMID: 938183 BACKGROUND

• Birkbak J, Clark AJ, Rod NH. The effect of sleep disordered breathing on the outcome of stroke and transient ischemic attack: a systematic review. J Clin Sleep Med. 2014 Jan 15;10(1):103-8. doi: 10.5664/jcsm.3376.

  PMID: 24426829 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine Carotid plaque

MeSH Terms

Conditions

Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central; Sleep Deprivation; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Renaud Tamisier, MD, PhD, MBA

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Baillieul, MD, MSc

CONTACT

+33 (0)4 76 76 75 40; sbaillieul@chu-grenoble.fr

Sara Saadi, MSc

CONTACT

+33 (0)4 76 76 86 90; ssaadi1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: May 22, 2020
• Study Start: July 13, 2020
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2035
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

FR (1)