NCT00357513

Brief Summary

This study will characterize the gene response of the body's immune and inflammatory cells to stroke. There is a wide variation in stroke risk, stroke outcome, and response to clot-busting therapy for stroke. This variation may be due to differences in people's response to injury or infection, or to differences in genetic make-up between individuals. Genes store the biological information that determines the body's response to injury or infection. This study will analyze the activity of a large number of genes to try to learn which genes might be related to patient outcome. This, in turn, may lead to an understanding of which gene profiles are related to increased stroke risk and increased disability or death. Healthy volunteers over age 21 and stroke patients over age 21 who are admitted to the NIH Stroke Program at Suburban Hospital in Bethesda, Md., may be eligible for this study. Volunteers will be screened with a medical history, blood pressure and pulse measurements, electrocardiogram, and neurological examination. Participants will have 20 to 35 milliliters (about an ounce) of blood drawn for genetic studies. The genetic material will be extracted from the white blood cells and analyzed for normal and abnormal gene activity related to stroke. ...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2002

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

June 3, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2008

Completed
Last Updated

July 2, 2017

Status Verified

December 15, 2008

First QC Date

July 26, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Cerebrovascular DiseaseGene ChipInflammationPathophysiology StrokeStroke GenomicsStroke SubtypesNeuroimagingClinical Outcome MeasuresStrokeCVAHealthy VolunteerHVNormal Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HEALTHY VOLUNTEERS:
  • Over age 21
  • Healthy
  • Willing to participate in the study
  • Informed consent obtained
  • ACUTE STROKE PATIENTS:
  • Stroke patients admitted to Suburban or Holy Cross Hospitals
  • Over age 21
  • Willing to participate in the study
  • Informed Consent obtained

You may not qualify if:

  • HEALTHY VOLUNTEERS:
  • Active medical problems
  • Current symptomatic infection
  • Current severe allergic disorders
  • STROKE PATIENTS:
  • Cardiovascular instability
  • Severe anemia (hemoglobin less than 8.0 gm/dl)
  • Hemorrhagic diathesis
  • Current infection
  • Current severe allergic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Holy Cross Hospital, Silver Spring

Silver Spring, Maryland, 20902, United States

Location

Related Publications (3)

  • Acierno JS Jr, Kennedy JC, Falardeau JL, Leyne M, Bromley MC, Colman MW, Sun M, Bove C, Ashworth LK, Chadwick LH, Schiripo T, Ma S, Goldin E, Schiffmann R, Slaugenhaupt SA. A physical and transcript map of the MCOLN1 gene region on human chromosome 19p13.3-p13.2. Genomics. 2001 Apr 15;73(2):203-10. doi: 10.1006/geno.2001.6526.

    PMID: 11318610BACKGROUND
  • Baird AE, Benfield A, Schlaug G, Siewert B, Lovblad KO, Edelman RR, Warach S. Enlargement of human cerebral ischemic lesion volumes measured by diffusion-weighted magnetic resonance imaging. Ann Neurol. 1997 May;41(5):581-9. doi: 10.1002/ana.410410506.

    PMID: 9153519BACKGROUND
  • Baird AE, Warach S. Magnetic resonance imaging of acute stroke. J Cereb Blood Flow Metab. 1998 Jun;18(6):583-609. doi: 10.1097/00004647-199806000-00001.

    PMID: 9626183BACKGROUND

MeSH Terms

Conditions

Cerebrovascular DisordersStrokeInflammation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

June 3, 2002

Study Completion

December 15, 2008

Last Updated

July 2, 2017

Record last verified: 2008-12-15

Locations