NCT01172977

Brief Summary

It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

July 28, 2010

Last Update Submit

June 21, 2011

Conditions

StrokeDiabetes Mellitus

Keywords

Diabetes mellitusStroke

Outcome Measures

Primary Outcomes (1)

  • Functional outcome six months after the cerebral ischemia

    Functional outcome for the National Institutes of Health Stroke scale, the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia.

    six months

Secondary Outcomes (2)

  • Additional cerebral ischemia

    six months

  • Mortality

    sixt months

Study Arms (2)

HbA1c ≤ 7

Stroke patients with mild diabetes mellitus HbA1c ≤ 7

HbA1c ≥ 7,5

Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

You may qualify if:

  • Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

You may not qualify if:

  • Patients with intracerebral hemorrhage
  • Pregnant patients
  • Patients with sensory aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelisches Krankenhaus

Bielefeld, 33167, Germany

Location

MeSH Terms

Conditions

StrokeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cristian Barzu, MD

    Evangelisches Krankenhaus Bielefeld, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

DE(1)