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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472381
First Posted: May 11, 2007
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Resource links provided by NLM:


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) [ Time Frame: during the study ]

Enrollment: 180
Study Start Date: May 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Insulin
Drug: Insulin
Insulin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472381


Locations
France
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Poissy, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves Samson, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00472381     History of Changes
Other Study ID Numbers: P060202
First Submitted: May 10, 2007
First Posted: May 11, 2007
Last Update Posted: June 5, 2014
Last Verified: September 2012

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

Additional relevant MeSH terms:
Stroke
Ischemia
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs