NCT06031909|Unknown
Multimodal Assessment of Frailty in Acute Stroke Patients
MAFASP
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MAFASP
Sponsor study identifier
observational
200
1 country
1
Study Start
August 1, 2023
Actual (reported)Primary Completion
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2023
Actual (reported)August 30, 2023
Actual (reported)September 11, 2023
Actual (reported)October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prevalence of frailty in stroke patients
Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke
30 days
Rate of good functional outcome
Percentage of patients achieving a score of 0 to 2 on the modified Rankin scale (higher values indicating worse outcome, ranging from 0, no deficit, to 6, death) at 12 months follow-up
12 months
Patient reported outcome measures (PROM)
12 months
Functional impairment in activities of daily living
12 months
Mortality rate
From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.
Cognitive outcome
12 months
Rate of rehospitalization
12 months
Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.
Different domains are assessed during hospital stay, these include: * Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI) * Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging * Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers * Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS) * Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients admitted with the diagnosis of acute stroke treated at the certified stroke-unit will be included. All patients who consent for participation are further eligible for the outcome assessment.
Department of Neurology, University Hospital Giessen
Giessen, Hesse, 35392, Germany
Giede-Jeppe A, Bobinger T, Gerner ST, Sembill JA, Sprugel MI, Beuscher VD, Lucking H, Hoelter P, Kuramatsu JB, Huttner HB. Neutrophil-to-Lymphocyte Ratio Is an Independent Predictor for In-Hospital Mortality in Spontaneous Intracerebral Hemorrhage. Cerebrovasc Dis. 2017;44(1-2):26-34. doi: 10.1159/000468996. Epub 2017 Apr 19.
Giede-Jeppe A, Reichl J, Sprugel MI, Lucking H, Hoelter P, Eyupoglu IY, Kuramatsu JB, Huttner HB, Gerner ST. Neutrophil-to-lymphocyte ratio as an independent predictor for unfavorable functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Feb 1;132(2):400-407. doi: 10.3171/2018.9.JNS181975. Print 2020 Feb 1.
Stefan Gerner, MD
Department of Neurology, University Hospital Giessen/Germany
Thorsten Doeppner, MD
Department of Neurology, University Hospital Giessen/Germany
Hagen Huttner, MD, PhD
Department of Neurology, University Hospital Giessen/Germany
First Submitted
August 30, 2023
First Posted
September 11, 2023
Study Start
August 1, 2023
Actual (reported)Primary Completion
October 31, 2024
Estimated (date passed)Frailty Rehabilitation
Contact the study team to confirm eligibility.
Gerner ST, Reichl J, Custal C, Brandner S, Eyupoglu IY, Lucking H, Holter P, Kallmunzer B, Huttner HB. Long-Term Complications and Influence on Outcome in Patients Surviving Spontaneous Subarachnoid Hemorrhage. Cerebrovasc Dis. 2020;49(3):307-315. doi: 10.1159/000508577. Epub 2020 Jul 3.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 11, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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