<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721538</url>
  </required_header>
  <id_info>
    <org_study_id>SCENARIO OP1</org_study_id>
    <nct_id>NCT01721538</nct_id>
  </id_info>
  <brief_title>Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction</brief_title>
  <acronym>SCENARIO</acronym>
  <official_title>Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Von Behring-Röntgen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Philipps University Marburg Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary&#xD;
      prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with&#xD;
      two arms. The therapy arm is participating in a comprehensive weight reducing program,&#xD;
      whereas the control group takes part in a lecture on healthy nutrition. The primary study&#xD;
      objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary&#xD;
      prevention of stroke. Secondary objectives are functional outcome, cognitive status, post&#xD;
      stroke depression, and health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <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.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>18 months</time_frame>
    <description>Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive deficits</measure>
    <time_frame>18 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post stroke depression</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of arterial hypertension, diabetes mellitus and hyperlipidemia</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Stroke</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Therapy arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-drug therapeutic weight reduction program (15 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lecture on healthy nutrition (1 hour)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight reduction program</intervention_name>
    <arm_group_label>Therapy arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lecture on healthy nutrition</intervention_name>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of ischemic stroke&#xD;
&#xD;
          -  Age: 20 - 85 years&#xD;
&#xD;
          -  BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm&#xD;
&#xD;
          -  Functional impairment, which would allow to participate in weight reduction program&#xD;
             (mRS 0-4, NIHSS 0-12)&#xD;
&#xD;
          -  Patient must be capable of understanding informed consent&#xD;
&#xD;
          -  Written informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an&#xD;
             exclusion criterion)&#xD;
&#xD;
          -  Speech disturbance (aphasia or sever dysarthria)&#xD;
&#xD;
          -  Dimming of consciousness&#xD;
&#xD;
          -  Stroke due to arterial dissection or coagulation disorder&#xD;
&#xD;
          -  Drug-related weight changes during previous 3 months&#xD;
&#xD;
          -  Changes in appetite influencing medication listed in appendix during previous 3 months&#xD;
&#xD;
          -  Bariatric surgery in the past&#xD;
&#xD;
          -  Diabetes mellitus with a history of severe ketoacidosis&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Severe co-morbid disorders, e.g.:&#xD;
&#xD;
               -  AV-Block ≥ 2nd degree&#xD;
&#xD;
               -  Heart insufficiency (NYHA &gt; 2)&#xD;
&#xD;
               -  Pericarditis, pericardial effusion&#xD;
&#xD;
               -  Severe kidney insufficiency (Creatinine &gt; 3 mg/dl; Urea &gt; 150 mg/dl)&#xD;
&#xD;
               -  Hepatic insufficiency (GOT &gt; 3 x ULN; GPT &gt; 3 x ULN)&#xD;
&#xD;
               -  Severe psychiatric disease within the last six months (psychosis, suicide&#xD;
                  attempts)&#xD;
&#xD;
               -  Chronic alcohol addiction or drug addiction&#xD;
&#xD;
               -  HIV- or hepatitis infection&#xD;
&#xD;
               -  Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months&#xD;
                  prior to start of obesity program)&#xD;
&#xD;
          -  Cognitive impairment with MMSE &lt; 20&#xD;
&#xD;
          -  Depression with BDI &gt; 20&#xD;
&#xD;
          -  Patients who are unable to give consent to study participation (MMSE &lt; 20, aphasia)&#xD;
&#xD;
          -  Recurrent stroke or myocardial infarction in the period between screening for study&#xD;
             participation and start of weight reduction program&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yaroslav Winter, MD</last_name>
    <phone>00496421-5865200</phone>
    <email>wintery@med.uni-marburg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Neurology, Philipps-University Marburg</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Winter Yaroslav, MD</last_name>
      <phone>004964215865200</phone>
      <email>wintery@med.uni-marburg.de</email>
    </contact>
    <investigator>
      <last_name>Yaroslav Winter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18703800</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Philipps University Marburg Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Yaroslav Winter</investigator_full_name>
    <investigator_title>Neurologist and Research Fellow</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>prevention</keyword>
  <keyword>obesity</keyword>
  <keyword>weight reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721538
org study id: SCENARIO OP1
nct id: NCT01721538
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
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
measure: Functional outcome
time frame: 18 months
description: Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)
measure: Cognitive deficits
time frame: 18 months
description: 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
measure: Post stroke depression
time frame: 18 months
description: 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.
measure: Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
time frame: 18 months
arm group label: Therapy arm
arm group type: Experimental
description: Non-drug therapeutic weight reduction program (15 weeks)
arm group label: Control arm
arm group type: Placebo Comparator
description: Lecture on healthy nutrition (1 hour)
intervention type: Other
intervention name: Weight reduction program
arm group label: Therapy arm
intervention type: Other
intervention name: Lecture on healthy nutrition
arm group label: Control arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yaroslav Winter, MD
phone: 00496421-5865200
email: wintery@med.uni-marburg.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
citation: 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.
PMID: 18703800
responsible party type: Principal Investigator
investigator affiliation: Philipps University Marburg Medical Center
investigator full name: Dr. Yaroslav Winter
investigator title: Neurologist and Research Fellow
mesh term: Stroke
mesh term: Weight Loss