NCT03355690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

October 10, 2017

Last Update Submit

April 12, 2023

Conditions

Stroke

Keywords

thrombectomythrombolysisHealth-economic statusOutcome after stroke

Outcome Measures

Primary Outcomes (1)

  • Modified rankin scale

    Change in modified rankin scale over time: baseline (diagnosis stroke), 3 months and one year follow-up. Modified rankin scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

    day 1, 3 months and 12 months

Secondary Outcomes (8)

  • Rehabilitation: evaluation muscle strength

    day 1, 3 months and 12 months

  • Rehabilitation: evaluation arm/hand function

    day 1, 3 months and 12 months

  • Rehabilitation: walking capability

    day 1, 3 months and 12 months

  • Rehabilitation: trunk control test

    day 1, 3 months and 12 months

  • National Institutes of Health Stroke Scale (NIHSS)

    day 1, 3 months and 12 months

  • +3 more secondary outcomes

Study Arms (1)

Stroke patients

Stroke patients are treated according to the clinical practice which can be divided into: anti-aggregation, thrombectomy and/or thrombolysis

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 32849196DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sofie Vancauter, MD PhD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2017

First Posted

November 28, 2017

Study Start

December 15, 2017

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

BE(1)