NCT02171858

Brief Summary

Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.6 years

First QC Date

June 4, 2014

Last Update Submit

June 21, 2014

Conditions

Keywords

StrokeNational Institutes of Health Stroke ScaleSerum high sensitivity C-Reactive Protein

Outcome Measures

Primary Outcomes (1)

  • Measure of serum High sensitivity C-Reactive Protein level

    Serum levels of serum High sensitivity C-Reactive Protein will be measured in patients with suspicion of stroke at the emergency room within the first 8 hours of arrival at our hospital

    within the first 8 hours since admission to hospital

Secondary Outcomes (1)

  • National Institutes of Health Stroke Scale

    within the first 4 hours since admission to emergency room

Other Outcomes (3)

  • Stroke extension

    within the first 4 hours since admission to emergency room

  • Origin of stroke

    origin will be diagnosed during the hospital stay expecting no more than 1 week

  • Hospital stay

    hospital stay is expected for no more than 1 week unless intensive care unit is needed

Study Arms (1)

stroke

Patients admitted to hospital who are diagnosed with stroke will be treated as usually a our center by observation, venous or arterial thrombolysis depending on extension, condition, thrombolysis feasibility.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients affiliated to Petróleos Mexicanos medical system of any gender between 18 and 80 years old suspected of acute phase stroke who arrive to emergency room at our hospital

You may qualify if:

  • Patients suspected of acute phase stroke who arrive to emergency room at our hospital
  • Patients affiliated to Petróleos Mexicanos medical system
  • Patients of any gender
  • Patients between 18 and 80 years old

You may not qualify if:

  • Stroke provoked by angiographic procedure
  • Pregnancy
  • Patient under chemotherapy or radiotherapy
  • Recently surgery or trauma among last 30 days
  • Heparin usage
  • Stroke and/ or thrombolysis history
  • Active infection
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central Sur Alta Especialidad

Mexico City, Tlalpan, 14140, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 24, 2014

Study Start

June 1, 2013

Primary Completion

January 1, 2015

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations