StrokeMAASPNCT02171858
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke
An observational study of Stroke and National Institutes of Health Stroke Scale, run by Hospital Central Sur de Alta Especialidad at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, National Institutes of Health Stroke Scale, Serum High Sensitivity C-Reactive Protein
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Sur Alta Especialidad
Mexico City, Tlalpan, 14140
About this study
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.
- Conditions
- Stroke, National Institutes of Health Stroke Scale, Serum High Sensitivity C-Reactive Protein
- Keywords
- Stroke, National Institutes of Health Stroke Scale, Serum high sensitivity C-Reactive Protein
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within the first 8 hours since admission to hospital
Secondary outcomes (1)
National Institutes of Health Stroke Scale
clinical impact of stroke will be determined by neurology and neurosurgery department at admission to emergency room of our hospital
Measured: within the first 4 hours since admission to emergency room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central Sur de Alta Especialidad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Yanez, Hospital Central Sur de Alta Especialidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171858
- Sponsor's protocol ID
- CRP-S1
- Acronym
- MAASP
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke
- ClinicalTrials.gov ID
- NCT02171858
- Acronym / sponsor ID
- MAASP / CRP-S1
- Conditions
- Stroke, National Institutes of Health Stroke Scale, Serum High Sensitivity C-Reactive Protein
- Keywords
- Stroke, National Institutes of Health Stroke Scale, Serum high sensitivity C-Reactive Protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospital Central Sur de Alta EspecialidadUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Stroke provoked by angiographic procedure
- Pregnancy
- Patient under chemotherapy or radiotherapy
- Recently surgery or trauma among last 30 days
- Heparin usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of serum High sensitivity C-Reactive Protein level
Time frame: within the first 8 hours since admission to hospital
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
1 secondary outcome
National Institutes of Health Stroke Scale
Time frame: within the first 4 hours since admission to emergency room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and National Institutes of Health Stroke Scale, run by Hospital Central Sur de Alta Especialidad at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of serum High sensitivity C-Reactive Protein level (time frame: within the first 8 hours since admission to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.