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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03700879
Other study ID # PFOAISOIA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2020

Study information

Verified date October 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Age :> 18 years up to 49 years. In patients with Acute ischemic stroke within first 24 hours

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
3months
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