Clinical trial NCT03355690: The Care of Stroke in Ziekenhuis Oost-Limburg
Official title: The Care of Stroke in the Hospital of Genk: Outcome After Treatment and the Health-economic Impact of Stroke in the Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: thrombectomy
thrombolysis
Health-economic status
Outcome after stroke
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (older than 18 years) diagnosed with stroke will be asked to parcipate. When the patient is not approachable for participation, the next of kin will be informed. An informed consent has to be obtained before study participation.

Brief summary: A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.

Diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. However, little data is known. Unfortunately, the outcome after diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of Genk.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* older than 18 years
* diagnosed with stroke

Exclusion Criteria:

* younger than 18 years

Primary outcomes:
measure: Modified rankin scale
timeFrame: day 1, 3 months and 12 months
Secondary outcomes:
measure: Rehabilitation: evaluation muscle strength
timeFrame: day 1, 3 months and 12 months
measure: Rehabilitation: evaluation arm/hand function
timeFrame: day 1, 3 months and 12 months
measure: Rehabilitation: walking capability
timeFrame: day 1, 3 months and 12 months
measure: Rehabilitation: trunk control test
timeFrame: day 1, 3 months and 12 months
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 1, 3 months and 12 months
measure: Quality of life-EQ5D
timeFrame: day 1, 3 months and 12 months
measure: Quality of life-Barthel index
timeFrame: day 1, 3 months and 12 months
measure: Quality of life-stroke specific quality of life scale
timeFrame: day 1, 3 months and 12 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Sofie Vancauter, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lesenne A, Grieten J, Ernon L, Wibail A, Stockx L, Wouters PF, Dreesen L, Vandermeulen E, Van Boxstael S, Vanelderen P, Van Poucke S, Vundelinckx J, Van Cauter S, Mesotten D. Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set. Front Neurol. 2020 Jul 31;11:718. doi: 10.3389/fneur.2020.00718. eCollection 2020.