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Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke (INSULINFARCT)

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, May 2007

Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
CNRS UPR 640 LENA
Clinical Research Unit
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00472381
  Purpose

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.


Condition Intervention Phase
Acute Stroke
Acute Cerebral Ischemia
Drug: Insulin
Phase II
Phase III

Drug Information available for:   Insulin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Modified Rankin Scale at three months [ Time Frame: three months ]
  • Magnetic resonance imaging (MRI) infarct growth at one day [ Time Frame: one day ]
  • Percentage of patients with hypoglycaemic event (< 3 mmol/l)

Estimated Enrollment:   180
Study Start Date:   May 2007
Estimated Study Completion Date:   September 2009

Detailed Description:

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age over 18 years
  • Carotid territory stroke
  • MRI performed in the first five hours of stroke onset
  • Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
  • Time between MRI and treatment under one hour

Exclusion Criteria:

  • Pre-existing Modified Rankin Scale of three or higher
  • Advanced or terminal illness with risk of death in the next 6 months, addiction
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472381

Contacts
Contact: Yves Samson, MD,PhD     +33(0) 1 42 16 18 54     yves.samson@psl.aphp.fr    

Locations
France
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière     Recruiting
      POISSY, France, 75013
      Contact: Yves Samson, MD,PhD     +33(0) 1 42 16 18 54     yves.samson@psl.aphp.fr    

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
CNRS UPR 640 LENA
Clinical Research Unit

Investigators
Principal Investigator:     Yves Samson, MD,PhD     Assistance Publique - Hôpitaux de Paris    
  More Information


Publications of Results:

Study ID Numbers:   P060202, SCR06011
First Received:   May 10, 2007
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00472381
Health Authority:   France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Ischemic Stroke  
Post-Stroke Hyperglycaemia  
Insulin treatment  
Insulin
DWI
MRI

Study placed in the following topic categories:
Hyperglycemia
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008




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