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Ischemic StrokeISOTNCT04196894

Ischemic Stroke, Obesity and Thrombolysis

An observational study of Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
How many people
280 participants
Where
2 sitesSwitzerland
Study dates
1 Mar 2015to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites
  • Kantonsspital St.Gallen

    Sankt Gallen

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: Ischemic Stroke, Obesity and Thrombolysis (ISOT)

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.

Conditions
Ischemic Stroke
Keywords
Thrombolysis, Obesity, Acute ischemic stroke
Medical subject headings
Ischemic Stroke, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 3

Secondary outcomes (4)
  1. Symptomatic intracranial hemorrhage at 24h after intravenous thrombolysis

    Measured: Day 1

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

    Measured: Day 1

  3. In-hospital complications

    Measured: Day 1

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

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2019
  2. Study start1 Mar 2015
  3. Primary completion29 Feb 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04196894
Sponsor's protocol ID
367/14
Acronym
ISOT
Status last verified
Dec 2024
First submitted
6 Dec 2019
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of favourable clinical outcome (mRS 0-2) and death (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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