NCT04196894

Brief Summary

This study focuses on the relationship between obesity and stroke, which are both characterized by increasing incidence and prevalence with epidemic proportions worldwide and tremendous socio-economic consequences. Furthermore, obesity is an established risk factor for stroke and affects especially younger people, which increases the stroke incidence in younger patients. Unfortunately, the relationship between overweight and acute ischemic stroke including treatment by thrombolysis has not yet been evaluated thoroughly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 1, 2015

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

9 years

First QC Date

December 6, 2019

Last Update Submit

December 5, 2024

Conditions

Keywords

ThrombolysisObesityAcute ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Rates of favourable clinical outcome (mRS 0-2) and death

    Month 3

Secondary Outcomes (4)

  • Symptomatic intracranial hemorrhage at 24h after intravenous thrombolysis

    Day 1

  • Recanalisation rates of vessel occlusion at 24h after thrombolysis

    Day 1

  • In-hospital complications

    Day 1

  • Stroke recurrence and myocardial infarction within 12 months after thrombolysis

    Month 12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving thrombolytic treatment for acute ischemic stroke will be included in this study.

You may qualify if:

  • Acute ischemic stroke
  • Acute treatment with thrombolysis
  • Age \>18 years
  • Written informed consent

You may not qualify if:

  • Age \<18 years
  • Intracranial hemorrhage
  • Known hemorrhagic diathesis
  • Preexisting neurological deficits (mRS \>2 points)
  • Uncontrolled arterial hypertension (blood pressure \>185/110 mmHg repeatedly despite antihypertensive drugs)
  • Severe illness with poor prognosis (e.g. neoplasia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Ischemic StrokeObesity

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hakan Sarikaya, PD Dr.med.

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 12, 2019

Study Start

March 1, 2015

Primary Completion

February 29, 2024

Study Completion

March 31, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations