- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02171858
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke (MAASP)
June 21, 2014 updated by: Jorge Yanez, Hospital Central Sur de Alta Especialidad
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tlalpan
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Mexico city, Tlalpan, Mexico, 14140
- Hospital Central Sur Alta Especialidad
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability 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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of serum High sensitivity C-Reactive Protein level
Time Frame: within the first 8 hours since admission to hospital
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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
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within the first 8 hours since admission to hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
National Institutes of Health Stroke Scale
Time Frame: within the first 4 hours since admission to emergency room
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clinical impact of stroke will be determined by neurology and neurosurgery department at admission to emergency room of our hospital
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within the first 4 hours since admission to emergency room
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke extension
Time Frame: within the first 4 hours since admission to emergency room
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brain image will be taken as soon as possible when patient suspected with stroke arrives to emergency room and after clinical evaluation
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within the first 4 hours since admission to emergency room
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Origin of stroke
Time Frame: origin will be diagnosed during the hospital stay expecting no more than 1 week
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origin of stroke will be investigated within hospital stay
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origin will be diagnosed during the hospital stay expecting no more than 1 week
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Hospital stay
Time Frame: hospital stay is expected for no more than 1 week unless intensive care unit is needed
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from arrival of patient to emergency room until discharge
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hospital stay is expected for no more than 1 week unless intensive care unit is needed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
June 21, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 21, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRP-S1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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