Acute StrokeNCT03700879
Predictive Factors Of Acute Ischemic Stroke Outcome in Adult
An observational study of Acute Stroke, run by Assiut University.
Trial summary
Stroke is a devastating disease that affects 15 million patients worldwide each year, resulting in death in about one-third of patients and severe disability in two-thirds of the survivors. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Dec 2020
- 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 49 years
- All sexes
- Adult
Study population: In this cross sectional study, the entire data of patients with definite diagnosis of cerebrovascular attack (CVA in assuit university hospitals from september 2018 until September 2019, prospectively) will be analyzed . Patients having clinical neurological deficit of acute onset in the first 24 hours with distinct area of infarction by neuro-imaging will be included.
Who may be able to join
- Age :> 18 years up to 49 years. In patients with Acute ischemic stroke within first 24 hours
Who cannot join
- Disability prior to the present stroke (mRS >3) Patients youner than 18 or older than 49 years Patients refusing to continue the study will be excluded
About this study
Stroke is a devastating disease that affects 15 million patients worldwide each year, resulting in death in about one-third of patients and severe disability in two-thirds of the survivors.
Ischemic stroke in young adults is often thought to be related to rare risk factors and etiological features that are very different from the 'traditional' vascular risk factors and etiology seen in older stroke patients. However, the increase in stroke incidence in young adults has been found to be associated with a rising prevalence of some important traditional vascular risk factors, including hypertension, hypercholesterolemia, diabetes mellitus and obesity, in this age group.
Read more
Risk factors Modifiable risk factors are the same for both younger and older age groups. However, the prevalence of these risk factors is not the same in these two age groups. Hypertension, heart disease (including atrial fibrillation), and diabetes mellitus are the most common risk factors among the elderly A considerable minority of ischemic stroke cases remains etiologic-ally undefined However, there is still scant information on the role of risk factors and the clinical course in etiologic stroke sub-types.
Although the risk factors of ischemic strokes are well defined, there is slight information about their relations with the etiologies of ischemic strokes. This study will investigate the distribution of ischemic stroke risk factors and their connections to diverse etiologies of cerebrovascular attack (CVA) and specific ischemic regions of brain.
Considering that the prevalence of stroke risk factors rises with aging, the incidence of stroke will increase in further decades as the populations get older. The mortality and morbidity of each stroke pattern is different. So realizing the relation between stroke risk factors and its patterns can show the burden of preventing and treating every risk factor on the outcome of stroke.
Read the detailed description
Stroke is a devastating disease that affects 15 million patients worldwide each year, resulting in death in about one-third of patients and severe disability in two-thirds of the survivors. Approximately 80% of all strokes are ischemic strokes, of which roughly 10% occur in individuals under the age of 50 years-so-called 'young stroke.
In Egypt, the total lifetime prevalence of stroke was 8.5/1,000 in the population aged 20 years and more.
Age limits defining adult stroke differ across studies, but most studies define adult stroke as an ischemic stroke in persons aged 18-49 years, as this was the age range generally used in large studies.
In recent years, a remarkable, unprecedented decrease in the average age of onset of ischemic stroke in the overall population was witnessed , which is mainly attributable to an increased incidence of stroke in young adults. Ischemic stroke in young adults is often thought to be related to rare risk factors and etiological features that are very different from the 'traditional' vascular risk factors and etiology seen in older stroke patients. However, the increase in stroke incidence in young adults has been found to be associated with a rising prevalence of some important traditional vascular risk factors, including hypertension, hypercholesterolaemia, diabetes mellitus and obesity, in this age group.
In addition to the identification of risk factors and etiology, long-term prognosis after stroke is of particular interest from the perspective of young patients, as they usually have a life expectancy of several decades. Following a stroke, these individuals are suddenly confronted with uncertainties about their future in a period of life during which they might be preparing for decisive career moves or planning a family. Therefore, information on long-term prognosis should include not only the risk of vascular and other diseases, but also the expected psycho-social consequences related to life after stroke-a topic reported to be among the top 10 research priorities for patients.
Risk factors Modifiable risk factors are the same for both younger and older age groups. However, the prevalence of these risk factors is not the same in these two age groups. Hypertension, heart disease (including atrial fibrillation), and diabetes mellitus are the most common risk factors among the elderly. In contrast, among young stroke patients, the most common vascular risk factors were dyslipidemia , smoking, and hypertension.
A considerable minority of ischemic stroke cases remains etiologic-ally undefined However, there is still scant information on the role of risk factors and the clinical course in etiologic stroke sub-types.
Although the risk factors of ischemic strokes are well defined, there is slight information about their relations with the etiologies of ischemic strokes. This study will investigate the distribution of ischemic stroke risk factors and their connections to diverse etiologies of cerebrovascular attack (CVA) and specific ischemic regions of brain.
Considering that the prevalence of stroke risk factors rises with aging, the incidence of stroke will increase in further decades as the populations get older. The mortality and morbidity of each stroke pattern is different. So realizing the relation between stroke risk factors and its patterns can show the burden of preventing and treating every risk factor on the outcome of stroke.
- Conditions
- Acute Stroke
- Being tested
- MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI,MRA,Carotid ,vertebrobasilar and Transcranial DopplerRadiation
Patients presented with clinical picture and radiography suggestive of acute ischemic stroke will be subjected to a comprehensive evaluation with MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse prognostic factors of acute ischemic stroke in adults.
Modified rankin scale (mRS) for measuring the degree of disability. it is scale contain six items 0 mean no symptoms and 6 mean dead and good outcome equal or less than 2
No symptoms at all0 No significant disability despite symptoms; able to carry out all usual duties and activities+1 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance+2 Moderate disability; requiring some help, but able to walk without assistance+3 Moderately severe disability; unable to walk and attend to bodily needs without assistance+4 Severe disability; bedridden, incontinent and requiring constant nursing care and attention+5 Dead+6 A standardized interview also exists to try to reduce subjectivity or variability in score
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Atif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700879
- Sponsor's protocol ID
- PFOAISOIA
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Of Acute Ischemic Stroke Outcome in Adult
- ClinicalTrials.gov ID
- NCT03700879
- Acronym / sponsor ID
- PFOAISOIA
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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 a devastating disease that affects 15 million patients worldwide each year, resulting in death in about one-third of patients and severe disability in two-thirds of the survivors.
Ischemic stroke in young adults is often thought to be related to rare risk factors and etiological features that are very different from the 'traditional' vascular risk factors and etiology seen in older stroke patients. However, the increase in stroke incidence in young adults has been found to be associated with a rising prevalence of some important traditional vascular risk factors, including hypertension, hypercholesterolemia, diabetes mellitus and obesity, in this age group.
Risk factors Modifiable risk factors are the same for both younger and older age groups. However, the prevalence of these risk factors is not the same in these two age groups. Hypertension, heart disease (including atrial fibrillation), and diabetes mellitus are the most common risk factors among the elderly A considerable minority of ischemic stroke cases remains etiologic-ally undefined However, there is still scant information on the role of risk factors and the clinical course in etiologic stroke sub-types.
Although the risk factors of ischemic strokes are well defined, there is slight information about their relations with the etiologies of ischemic strokes. This study will investigate the distribution of ischemic stroke risk factors and their connections to diverse etiologies of cerebrovascular attack (CVA) and specific ischemic regions of brain.
Considering that the prevalence of stroke risk factors rises with aging, the incidence of stroke will increase in further decades as the populations get older. The mortality and morbidity of each stroke pattern is different. So realizing the relation between stroke risk factors and its patterns can show the burden of preventing and treating every risk factor on the outcome of stroke.
Detailed description
Stroke is a devastating disease that affects 15 million patients worldwide each year, resulting in death in about one-third of patients and severe disability in two-thirds of the survivors. Approximately 80% of all strokes are ischemic strokes, of which roughly 10% occur in individuals under the age of 50 years-so-called 'young stroke.
In Egypt, the total lifetime prevalence of stroke was 8.5/1,000 in the population aged 20 years and more.
Age limits defining adult stroke differ across studies, but most studies define adult stroke as an ischemic stroke in persons aged 18-49 years, as this was the age range generally used in large studies.
In recent years, a remarkable, unprecedented decrease in the average age of onset of ischemic stroke in the overall population was witnessed , which is mainly attributable to an increased incidence of stroke in young adults. Ischemic stroke in young adults is often thought to be related to rare risk factors and etiological features that are very different from the 'traditional' vascular risk factors and etiology seen in older stroke patients. However, the increase in stroke incidence in young adults has been found to be associated with a rising prevalence of some important traditional vascular risk factors, including hypertension, hypercholesterolaemia, diabetes mellitus and obesity, in this age group.
In addition to the identification of risk factors and etiology, long-term prognosis after stroke is of particular interest from the perspective of young patients, as they usually have a life expectancy of several decades. Following a stroke, these individuals are suddenly confronted with uncertainties about their future in a period of life during which they might be preparing for decisive career moves or planning a family. Therefore, information on long-term prognosis should include not only the risk of vascular and other diseases, but also the expected psycho-social consequences related to life after stroke-a topic reported to be among the top 10 research priorities for patients.
Risk factors Modifiable risk factors are the same for both younger and older age groups. However, the prevalence of these risk factors is not the same in these two age groups. Hypertension, heart disease (including atrial fibrillation), and diabetes mellitus are the most common risk factors among the elderly. In contrast, among young stroke patients, the most common vascular risk factors were dyslipidemia , smoking, and hypertension.
A considerable minority of ischemic stroke cases remains etiologic-ally undefined However, there is still scant information on the role of risk factors and the clinical course in etiologic stroke sub-types.
Although the risk factors of ischemic strokes are well defined, there is slight information about their relations with the etiologies of ischemic strokes. This study will investigate the distribution of ischemic stroke risk factors and their connections to diverse etiologies of cerebrovascular attack (CVA) and specific ischemic regions of brain.
Considering that the prevalence of stroke risk factors rises with aging, the incidence of stroke will increase in further decades as the populations get older. The mortality and morbidity of each stroke pattern is different. So realizing the relation between stroke risk factors and its patterns can show the burden of preventing and treating every risk factor on the outcome of stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Age groups
- Adult
- Study population
- In this cross sectional study, the entire data of patients with definite diagnosis of cerebrovascular attack (CVA in assuit university hospitals from september 2018 until September 2019, prospectively) will be analyzed . Patients having clinical neurological deficit of acute onset in the first 24 hours with distinct area of infarction by neuro-imaging will be included.
Key inclusion criteria (1 listed)
- Age :> 18 years up to 49 years. In patients with Acute ischemic stroke within first 24 hours
Key exclusion criteria (1 listed)
- Disability prior to the present stroke (mRS >3) Patients youner than 18 or older than 49 years Patients refusing to continue the study will be excluded
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 |
|---|---|---|
| MRI,MRA,Carotid ,vertebrobasilar and Transcranial DopplerPatients presented with clinical picture and radiography suggestive of acute ischemic stroke will be subjected to a comprehensive evaluation with MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler | Radiation | – |
Primary outcome
Analyse prognostic factors of acute ischemic stroke in adults.
Time frame: 3months
Modified rankin scale (mRS) for measuring the degree of disability. it is scale contain six items 0 mean no symptoms and 6 mean dead and good outcome equal or less than 2 No symptoms at all0 No significant disability despite symptoms; able to carry out all usual duties and activities+1 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance+2 Moderate disability; requiring some help, but able to walk without assistance+3 Moderately severe disability; unable to walk and attend to bodily needs without assistance+4 Severe disability; bedridden, incontinent and requiring constant nursing care and attention+5 Dead+6 A standardized interview also exists to try to reduce subjectivity or variability in score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Assiut University.
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 1 inclusion and 1 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Analyse prognostic factors of acute ischemic stroke in adults. (time frame: 3months). 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 10 Oct 2018.