StrokeSCENARIONCT01721538
Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction
A study testing Weight reduction program and Lecture on healthy nutrition in people with Stroke and Obesity, run by Philipps University Marburg at 1 site in Germany.
Trial summary
SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- What is being tested?
- Weight reduction program and Lecture on healthy nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Apr 2015
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic stroke
- Age: 20 - 85 years
- BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
- Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
- Patient must be capable of understanding informed consent
- Written informed consent for participation in the study
Who cannot join
- Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
- Speech disturbance (aphasia or sever dysarthria)
- Dimming of consciousness
- Stroke due to arterial dissection or coagulation disorder
- Drug-related weight changes during previous 3 months
- Changes in appetite influencing medication listed in appendix during previous 3 months
Show all 24Show fewer
- Bariatric surgery in the past
- Diabetes mellitus with a history of severe ketoacidosis
- Pregnancy or nursing
- Severe co-morbid disorders, e.g.:
- AV-Block ≥ 2nd degree
- Heart insufficiency (NYHA > 2)
- Pericarditis, pericardial effusion
- Severe kidney insufficiency (Creatinine > 3 mg/dl; Urea > 150 mg/dl)
- Hepatic insufficiency (GOT > 3 x ULN; GPT > 3 x ULN)
- Severe psychiatric disease within the last six months (psychosis, suicide attempts)
- Chronic alcohol addiction or drug addiction
- HIV- or hepatitis infection
- Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program)
- Cognitive impairment with MMSE < 20
- Depression with BDI > 20
- Patients who are unable to give consent to study participation (MMSE < 20, aphasia)
- Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, Philipps-University Marburg
Marburg
Winter Yaroslav, MD, 004964215865200, wintery@med.uni-marburg.de
Yaroslav Winter, MD
About this study
Official title: Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.
- Being tested
- Weight reduction program, Lecture on healthy nutrition
- Keywords
- stroke, prevention, obesity, weight reduction
- Medical subject headings
- Stroke, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight reduction programOther
Lecture on healthy nutritionOther
| Study group | Role | What they receive |
|---|---|---|
| Therapy arm | Experimental | Non-drug therapeutic weight reduction program (15 weeks) Receives: Other: Weight reduction program |
| Control arm | Placebo comparator | Lecture on healthy nutrition (1 hour) Receives: Other: Lecture on healthy nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
Measured: 18 months
Secondary outcomes (4)
Functional outcome
Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
Measured: 18 months
Cognitive deficits
Cognitive deficits in terms of vascular dementia as measured by the Structural Interview for diagnosis of Alzheimer dementia and multi-infarct dementia (SIDAM), the Vascular Dementia Assessment Scale cognitive subscale (VADAS-Cog), Stroop test and the Trail Makin Test
Measured: 18 months
Post stroke depression
Post stroke depression as measured by Beck Depression Inventar (BDI II) and health-related quality of life (HrQoL) as measured by the EuroQol (EQ5D, visual analogue scale), Stroke Specific Quality of Life Scale, Stroke Impact Scale.
Measured: 18 months
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Von Behring-Röntgen Foundation
- Responsible party
- Principal investigator, Dr. Yaroslav Winter, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721538
- Sponsor's protocol ID
- SCENARIO OP1
- Acronym
- SCENARIO
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 2012
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winter Y, Rohrmann S, Linseisen J, Lanczik O, Ringleb PA, Hebebrand J, Back T. Contribution of obesity and abdominal fat mass to risk of stroke and transient ischemic attacks. Stroke. 2008 Dec;39(12):3145-51. doi: 10.1161/STROKEAHA.108.523001. Epub 2008 Aug 14.
PubMed 18703800
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01721538
- Acronym / sponsor ID
- SCENARIO / SCENARIO OP1
- Keywords
- stroke, prevention, obesity, weight reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Von Behring-Röntgen Foundation
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 5 Nov 2012 (estimated)
- 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.
SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy arm | Experimental | Other: Weight reduction programNon-drug therapeutic weight reduction program (15 weeks) |
| Control arm | Placebo comparator | Other: Lecture on healthy nutritionLecture on healthy nutrition (1 hour) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of ischemic stroke
- Age: 20 - 85 years
- BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
- Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
- Patient must be capable of understanding informed consent
Key exclusion criteria (24 listed)
- Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
- Speech disturbance (aphasia or sever dysarthria)
- Dimming of consciousness
- Stroke due to arterial dissection or coagulation disorder
- Drug-related weight changes during previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight reduction program | Other | Therapy arm |
| Lecture on healthy nutrition | Other | Control arm |
Primary outcome
The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
Time frame: 18 months
4 secondary outcomes
Functional outcome
Time frame: 18 months
Cognitive deficits
Time frame: 18 months
Post stroke depression
Time frame: 18 months
Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- Background: PubMed 18703800Winter Y, Rohrmann S, Linseisen J, Lanczik O, Ringleb PA, Hebebrand J, Back T. Contribution of obesity and abdominal fat mass to risk of stroke and transient ischemic attacks. Stroke. 2008 Dec;39(12):3145-51. doi: 10.1161/STROKEAHA.108.523001. Epub 2008 Aug 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight reduction program and Lecture on healthy nutrition in people with Stroke and Obesity, run by Philipps University Marburg at 1 site in Germany.
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 6 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaroslav Winter, MD (00496421-5865200, wintery@med.uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721538, which also lists 1 linked publication.
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 5 Nov 2012.