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.
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
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.
Rates of favourable clinical outcome (mRS 0-2) and death
Measured: Month 3
Secondary outcomes (4)
Symptomatic intracranial hemorrhage at 24h after intravenous thrombolysis
Measured: Day 1
Recanalisation rates of vessel occlusion at 24h after thrombolysis
Measured: Day 1
In-hospital complications
Measured: Day 1
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.
- First posted12 Dec 2019
- Study start1 Mar 2015
- Primary completion29 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakan Sarikaya, PD Dr.med., Study chair, Insel Gruppe AG, University Hospital Bern
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Stroke, Obesity and Thrombolysis (ISOT)
- ClinicalTrials.gov ID
- NCT04196894
- Acronym / sponsor ID
- ISOT / 367/14
- Conditions
- Ischemic Stroke
- Keywords
- Thrombolysis, Obesity, Acute ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving thrombolytic treatment for acute ischemic stroke will be included in this study.
Key inclusion criteria (4 listed)
- Acute ischemic stroke
- Acute treatment with thrombolysis
- Age >18 years
- Written informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of favourable clinical outcome (mRS 0-2) and death
Time frame: Month 3
4 secondary outcomes
Symptomatic intracranial hemorrhage at 24h after intravenous thrombolysis
Time frame: Day 1
Recanalisation rates of vessel occlusion at 24h after thrombolysis
Time frame: Day 1
In-hospital complications
Time frame: Day 1
Stroke recurrence and myocardial infarction within 12 months after thrombolysis
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Sarikaya, PD Dr.med. study chair
Insel Gruppe AG, University Hospital Bern
2 sites in 1 country: see every site and its status.
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.