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Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction (SCENARIO)

This study is currently recruiting participants.
Verified November 2012 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
Von Behring-Röntgen Foundation
Information provided by (Responsible Party):
Dr. Yaroslav Winter, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01721538
First received: November 1, 2012
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Obesity
 Other: Weight reduction program
Other: Lecture on healthy nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)

  • Cognitive deficits [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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

  • Post stroke depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Severity of arterial hypertension, diabetes mellitus and hyperlipidemia [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapy arm
Non-drug therapeutic weight reduction program (15 weeks)
 Other: Weight reduction program
Placebo Comparator: Control arm
Lecture on healthy nutrition (1 hour)
 Other: Lecture on healthy nutrition

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721538

Contacts
Contact: Yaroslav Winter, MD 00496421-5865200 wintery@med.uni-marburg.de

Locations
Germany
Department of Neurology, Philipps-University Marburg Recruiting
Marburg, Germany
Contact: Winter Yaroslav, MD     004964215865200     wintery@med.uni-marburg.de    
Principal Investigator: Yaroslav Winter, MD            
Sponsors and Collaborators
Philipps University Marburg Medical Center
Von Behring-Röntgen Foundation
  More Information

Publications:

Responsible Party: Dr. Yaroslav Winter, Neurologist and Research Fellow, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01721538     History of Changes
Other Study ID Numbers: SCENARIO OP1
Study First Received: November 1, 2012
Last Updated: November 2, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
stroke
prevention
obesity
weight reduction

Additional relevant MeSH terms:
Obesity
Stroke
Cerebral Infarction
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013