StrokeNCT02974192
Neopterin Effects on Ischemic Stroke
An observational study of Stroke, run by Assiut University at 1 site in Egypt.
Trial summary
Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neopterin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with first -ever acute onset ischemic stroke within 24-48 hours
Who may be able to join
- Onset is within one week
- Confirmed stroke by brain CAT and / or MRI scan infarction
Who cannot join
- Cognitive and mental changes
- Recurrent stroke
- Hepatic and renal impairment
- Endocrinal diseases
- Steroid therapy
- Previous fractures
Show all 13Show fewer
- brain neoplasm,
- Autoimmune diseases
- History of acute and chronic inflammatory diseases
- Malignancy,
- Trauma
- Surgery
- Acute vascular diseases that occurred within four weeks prior the onset of stroke History myocardial infarction ˂3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut, Asyut Governorate
mohamed abdelatef, MD, 0020882413201, latif_mohamed@hotmail.com
About this study
Official title: Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective
Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Few studies have investigated the relationship between acute biomarkers of inflammation and functional outcome following stroke
Read the detailed description
This case -control observational prospective study will be conducted on 100 patients with first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean age ±years). All participants will be subjected to thorough history taking, full clinical and neurological examination. Complete neurological examination where the following clinical and demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar Duplex will be done for all patients. Blood samples will be drawn for assessment of complete blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin by using standard laboratory methods on the first day of admission.
- Conditions
- Stroke
- Being tested
- Neopterin
- Keywords
- Ischemic stroke, Soluble CD40 Ligand, Neopetrin, stroke risk factors, functional outcome
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeopterinOther
Neopterin will be measured by using standard laboratory methods on the first day of admission.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neopterin level
will be measured by using standard laboratory methods on the first day of admission
Measured: Within the first 24 hours
Soluble CD40 Ligand
will be measured by using standard laboratory methods on the first day of admission
Measured: Within the first 24 hours
Secondary outcomes (3)
Stroke subtype
will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification
Measured: Within the first 24 hours
The clinical stroke syndrome
will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)
Measured: Within the first 24 hours
Stroke severity
Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.
Measured: Within the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed k Abd-Elshafy, MD, Principal investigator, Associate professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974192
- Sponsor's protocol ID
- IIRB0000871432
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective
- ClinicalTrials.gov ID
- NCT02974192
- Acronym / sponsor ID
- IIRB0000871432
- Conditions
- Stroke
- Keywords
- Ischemic stroke, Soluble CD40 Ligand, Neopetrin, stroke risk factors, functional outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Nov 2016 (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.
Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Few studies have investigated the relationship between acute biomarkers of inflammation and functional outcome following stroke
Detailed description
This case -control observational prospective study will be conducted on 100 patients with first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean age ±years). All participants will be subjected to thorough history taking, full clinical and neurological examination. Complete neurological examination where the following clinical and demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar Duplex will be done for all patients. Blood samples will be drawn for assessment of complete blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin by using standard laboratory methods on the first day of admission.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with first -ever acute onset ischemic stroke within 24-48 hours
Key inclusion criteria (2 listed)
- Onset is within one week
- Confirmed stroke by brain CAT and / or MRI scan infarction
Key exclusion criteria (13 listed)
- Cognitive and mental changes
- Recurrent stroke
- Hepatic and renal impairment
- Endocrinal diseases
- Steroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeopterinNeopterin will be measured by using standard laboratory methods on the first day of admission. | Other | – |
Primary outcome
Neopterin level
Time frame: Within the first 24 hours
will be measured by using standard laboratory methods on the first day of admission
Soluble CD40 Ligand
Time frame: Within the first 24 hours
will be measured by using standard laboratory methods on the first day of admission
3 secondary outcomes
Stroke subtype
Time frame: Within the first 24 hours
The clinical stroke syndrome
Time frame: Within the first 24 hours
Stroke severity
Time frame: Within the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sayed k Abd-Elshafy, MD principal investigator
Associate professor of anesthesia
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, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 13 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 18 Jan 2017. 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 Egypt. 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?
Contact Sayed K Abd-Elshafy, MD (0020882413203, sayed_k_72@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neopterin level (time frame: Within the first 24 hours). The study lists 2 primary outcomes in all. 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 18 Jan 2017.