NCT02798770

Brief Summary

Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes. Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis. This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

June 2, 2016

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview

    Prehospital delay will be assessed by asking the Patient or witnesses how long the time interval between stroke onset and Hospital Admission is. For instance, if stroke symptoms have onset today at 3:00 PM and the Patient gets admitted today at 4:00 PM, prehospital delay is 1 hour.

    an average of 1 hour

Study Arms (1)

Stroke Center Basel

Other: No Intervention Foreseen

Interventions

Stroke Center Basel

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.

You may qualify if:

  • Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.

You may not qualify if:

  • Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse.
  • Patient not willing to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Center University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Fladt J, Meier N, Thilemann S, Polymeris A, Traenka C, Seiffge DJ, Sutter R, Peters N, Gensicke H, Fluckiger B, de Hoogh K, Kunzli N, Bringolf-Isler B, Bonati LH, Engelter ST, Lyrer PA, De Marchis GM. Reasons for Prehospital Delay in Acute Ischemic Stroke. J Am Heart Assoc. 2019 Oct 15;8(20):e013101. doi: 10.1161/JAHA.119.013101. Epub 2019 Oct 2.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc Priv. Doz.

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 14, 2016

Study Start

August 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Ready to share/pool data. The plan to make individual participant data has to be elaborated with the interested Party.

Locations