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CompletedNCT04196894ISOTUpdated Dec 6, 2024

Ischemic Stroke, Obesity and Thrombolysis

An observational study in Ischemic Stroke, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

All patients receiving thrombolytic treatment for acute ischemic stroke will be included in this study. The decision for treatment and selection of thrombolysis type is allocated to treating stroke physicians who will follow national and international stroke guidelines and considering the clinical and radiological findings. Patients are given either a) intravenous rt-PA (0.9 mg/kg; maximum 90 mg, 10% as intravenous bolus and the remaining 90% as continuous infusion over 1 hour), b) endovascular treatment such as intra-arterial urokinase or rt-PA and/or mechanical recanalization techniques, or c) two thirds of the standard dose intravenous rt-PA followed by endovascular treatment such as intra-arterial urokinase or rt-PA and/or mechanical recanalization techniques (bridging concept). Patient involvement in this study will not influence any treatment decision. Patients will undergo a complete diagnostic stroke work-up, including assessment of vascular risk factors and medication, clinical neurological examination using the National Institutes of Health Stroke Scale (NIHSS) score on admission and 24h after thrombolysis, laboratory examination, brain and neurovascular imaging, echocardiography and 24-hours ECG to determine stroke etiology using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. All patients will be weighed as early as possible, but stringently within 24h after thrombolysis. If they are able to stand at 24h, a standard calibrated licensed scale will be used (Seca, Hamburg, Germany; Model 799). Otherwise, patients will be weighed on a special bed scale calibrated and validated for the use for patient weighing (Seca; Hamburg, Germany; Model 657). In addition, body height, waist and hip circumference of each patient will be measured. All patients will be examined by CT and CTA or MRI and MRA at 24h and in any case of clinical deterioration to exclude intracranial hemorrhage and to assess recanalization in case of vessel occlusion (using the thrombolysis in myocardial infarction (TIMI) grading system). The treating physician will initiate secondary prevention of stroke as soon as possible and according to current guidelines. Body weight and clinical assessments (measurement of clinical scores NIHSS, modified Rankin Scale, and Barthel Index; assessment of adverse events such as in-hospital complication, death, cardiovascular event) will be performed by stroke physicians at following visits: I) day 3-5 and/or hospital discharge, II) 3-month and III) 12-month. Patients in whom a clinical follow-up examination is not possible will be evaluated by a structured phone interview.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • Thrombolysis
  • Obesity
  • Acute ischemic stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 280 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
280 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: Month 3

Secondary outcomes

  1. Symptomatic intracranial hemorrhage at 24h after intravenous thrombolysis

    Time frame: Day 1

  2. Recanalisation rates of vessel occlusion at 24h after thrombolysis

    Time frame: Day 1

  3. In-hospital complications

    Time frame: Day 1

  4. Stroke recurrence and myocardial infarction within 12 months after thrombolysis

    Time frame: Month 12

07

Study locations

2 sites
  • Kantonsspital St.Gallen
    St.Gallen, Switzerland
  • University Hospital Zurich
    Zurich, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04196894
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Dec 12, 2019
Start date
Mar 1, 2015
Primary completion
Feb 29, 2024
Completion
Mar 31, 2024
Last update
Dec 6, 2024

Study contacts

Hakan Sarikaya, PD Dr.med.
study chair · Insel Gruppe AG, University Hospital Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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