Clinical trial NCT02650531: Norwegian COgnitive Impairment After STroke (NorCOAST) Study
Official title: Norwegian COgnitive Impairment After STroke (NorCOAST) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Mild Cognitive Impairment
Stroke
Keywords: Follow up studies
Risk factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
name: Vestre Viken Hospital Trust
name: Haukeland University Hospital
name: University Hospital of North Norway
First posted: 2016-01-08
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute stroke

Brief summary: A prospective observational multicenter study aiming to describe incidence, and identify predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI) after stroke

Detailed description: About 15000 Norwegians suffer a stroke every year and 2/3 will be more or less disabled. In addition to motor impairments and comorbidities, disability after stroke is often related to post stroke dementia (PSD) or mild neurocognitive disorder (NCD). However, these problems are hardly addressed in stroke or dementia research and frequently ignored in clinical practise. In the Nor-COAST study an interdisciplinary research group will collaborate to establish a research platform across all Norwegian Health Authorities. The overall aim of the study is to improve competence on PSD and NCD in order to improve individual health outcomes following a stroke. The specific objectives are to determine the incidence of PSD and NCD and the consequences on function and use of health care services and to enhance the early detection of PSD and NCD by identifying a set of risk factors, ranging from genetics to physical activity. The incidence and impact of PSD and NCD on function and use of health care services, medication and life-style changes are important when planning future health care services. Tools identifying patients at risk might improve diagnostic work up and together with knowledge on pathogenic aspects it will contribute to future treatment and prevention of PSD and NCD.

Eligibility criteria: Inclusion Criteria:

* Stroke diagnosis according to the WHO criteria

Exclusion Criteria:

* Not scandinavian speaking

Primary outcomes:
measure: Score on the Montreal cognitive assessment (MOCA)
timeFrame: 18 months
Secondary outcomes:
measure: Score on the Montreal cognitive assessment (MOCA)
timeFrame: 3 months
measure: Time spent in upright position
timeFrame: 3 months
measure: Time spent in upright position
timeFrame: 18 months
measure: Brain Imaging
timeFrame: 18 months
measure: Score on Short Physical Performance Battery (sppb)
timeFrame: 3 months
measure: Score on Short Physical Performance Battery (sppb)
timeFrame: 18 months
measure: Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires
timeFrame: 3 months
measure: Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires
timeFrame: 18 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars Jacob Stovner, md prof
role: STUDY_DIRECTOR
References:
citation: Thingstad P, Askim T, Beyer MK, Brathen G, Ellekjaer H, Ihle-Hansen H, Knapskog AB, Lydersen S, Munthe-Kaas R, Naess H, Pendlebury ST, Seljeseth YM, Saltvedt I. The Norwegian Cognitive impairment after stroke study (Nor-COAST): study protocol of a multicentre, prospective cohort study. BMC Neurol. 2018 Nov 26;18(1):193. doi: 10.1186/s12883-018-1198-x.
citation: Waehler IS, Saltvedt I, Lydersen S, Fure B, Askim T, Einstad MS, Thingstad P. Association between in-hospital frailty and health-related quality of life after stroke: the Nor-COAST study. BMC Neurol. 2021 Mar 4;21(1):100. doi: 10.1186/s12883-021-02128-5.
citation: Gynnild MN, Hageman SHJ, Spigset O, Lydersen S, Saltvedt I, Dorresteijn JAN, Visseren FLJ, Ellekjaer H. Use of lipid-lowering therapy after ischaemic stroke and expected benefit from intensification of treatment. Open Heart. 2022 Apr;9(1):e001972. doi: 10.1136/openhrt-2022-001972.
citation: Munthe-Kaas R, Aam S, Saltvedt I, Wyller TB, Pendlebury ST, Lydersen S, Hagberg G, Schellhorn T, Rostoft S, Ihle-Hansen H. Is Frailty Index a better predictor than pre-stroke modified Rankin Scale for neurocognitive outcomes 3-months post-stroke? BMC Geriatr. 2022 Feb 19;22(1):139. doi: 10.1186/s12877-022-02840-y.
citation: Einstad MS, Thingstad P, Lydersen S, Gunnes M, Saltvedt I, Askim T. Physical Performance and Cognition as Predictors of Instrumental Activities of Daily Living After Stroke: A Prospective Multicenter Cohort Study. Arch Phys Med Rehabil. 2022 Jul;103(7):1320-1326. doi: 10.1016/j.apmr.2022.01.153. Epub 2022 Feb 16.
citation: Alme KN, Ulvik A, Askim T, Assmus J, Mollnes TE, Naik M, Naess H, Saltvedt I, Ueland PM, Knapskog AB. Neopterin and kynurenic acid as predictors of stroke recurrence and mortality: a multicentre prospective cohort study on biomarkers of inflammation measured three months after ischemic stroke. BMC Neurol. 2021 Dec 8;21(1):476. doi: 10.1186/s12883-021-02498-w.
citation: Alme KN, Askim T, Assmus J, Mollnes TE, Naik M, Naess H, Saltvedt I, Ueland PM, Ulvik A, Knapskog AB. Investigating novel biomarkers of immune activation and modulation in the context of sedentary behaviour: a multicentre prospective ischemic stroke cohort study. BMC Neurol. 2021 Aug 16;21(1):318. doi: 10.1186/s12883-021-02343-0.
citation: Schellhorn T, Zucknick M, Askim T, Munthe-Kaas R, Ihle-Hansen H, Seljeseth YM, Knapskog AB, Naess H, Ellekjaer H, Thingstad P, Wyller TB, Saltvedt I, Beyer MK. Pre-stroke cognitive impairment is associated with vascular imaging pathology: a prospective observational study. BMC Geriatr. 2021 Jun 14;21(1):362. doi: 10.1186/s12877-021-02327-2.
citation: Schellhorn T, Aamodt EB, Lydersen S, Aam S, Wyller TB, Saltvedt I, Beyer MK. Clinically accessible neuroimaging predictors of post-stroke neurocognitive disorder: a prospective observational study. BMC Neurol. 2021 Feb 25;21(1):89. doi: 10.1186/s12883-021-02117-8.
citation: Einstad MS, Saltvedt I, Lydersen S, Ursin MH, Munthe-Kaas R, Ihle-Hansen H, Knapskog AB, Askim T, Beyer MK, Naess H, Seljeseth YM, Ellekjaer H, Thingstad P. Associations between post-stroke motor and cognitive function: a cross-sectional study. BMC Geriatr. 2021 Feb 5;21(1):103. doi: 10.1186/s12877-021-02055-7.
citation: Munthe-Kaas R, Aam S, Saltvedt I, Wyller TB, Pendlebury ST, Lydersen S, Ihle-Hansen H. Test Accuracy of the Montreal Cognitive Assessment in Screening for Early Poststroke Neurocognitive Disorder: The Nor-COAST Study. Stroke. 2021 Jan;52(1):317-320. doi: 10.1161/STROKEAHA.120.031030. Epub 2020 Nov 30.
citation: Alme KN, Knapskog AB, Naess H, Naik M, Beyer M, Ellekjaer H, English C, Hansen HI, Kummeneje CS, Munthe-Kaas R, Saltvedt I, Seljeseth Y, Tan X, Thingstad P, Askim T. Is long-bout sedentary behaviour associated with long-term glucose levels 3 months after acute ischaemic stroke? A prospective observational cohort study. BMJ Open. 2020 Nov 26;10(11):e037475. doi: 10.1136/bmjopen-2020-037475.
citation: Gynnild MN, Aakeroy R, Spigset O, Askim T, Beyer MK, Ihle-Hansen H, Munthe-Kaas R, Knapskog AB, Lydersen S, Naess H, Rosstad TG, Seljeseth YM, Thingstad P, Saltvedt I, Ellekjaer H. Vascular risk factor control and adherence to secondary preventive medication after ischaemic stroke. J Intern Med. 2021 Mar;289(3):355-368. doi: 10.1111/joim.13161. Epub 2020 Aug 19.