Fatty LiverNCT06628700
Burden Fatty Liver Among Acute Ischemic Cerebral Stroke Patients
An observational study of Fatty Liver and Acute Ischemic Cerebral Stroke, run by Assiut University.
Trial summary
1. Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors 2. Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fatty Liver, Acute Ischemic Cerebral Stroke
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 10 Nov 2025
- How long will I take part?
- 20 Days
- 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 60 years
- All sexes
- Adult
Study population: Newly diagnosed ischemic cerebral stroke patients exceeding of window phase without obvious risk factors.
Who may be able to join
- Newly diagnosed ischemic cerebral stroke exceeding of window phase without obvious risk factors.
- patients above 18 years.
- patients below 60 years.
Who cannot join
- patients have obvious risk factors including: smoking, DM , Hypertension ,renal patients , cardiovascular diseases (AF , valvular disease ,reduced systolic function ,chronic HCV ,HBV).
- patients below 18 years.
- patients above 60 years.
- patients refused to contribute to this study.
Trial locations and contacts
No sites are listed yet.
About this study
- Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors
- Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis .
Read the detailed description
Fatty liver disease, encompassing both alcoholic and non-alcoholic variants, is a growing health concern worldwide, with prevalence rates soaring in parallel with obesity and diabetes epidemics. The estimated global incidence of NAFLD alone is 47 cases per 1,000 people, with a higher rate observed in males than females. Among adults worldwide, the estimated prevalence of NAFLD is 32%, with a higher prevalence in males (40%) compared to females (26%), making it the most common liver disorder. The hazards of fatty liver disease extend beyond the liver itself .The condition is characterized by the accumulation of excess fat in liver cells, which can progress to more severe liver diseases, such as steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
Early assessment and diagnosis of liver steatosis are crucial for managing and mitigating the risks associated with FLD. Non-invasive methods, such as elastography combined with the Controlled Attenuation Parameter (CAP) score, have emerged as effective tools for detecting and quantifying liver fat content. These methods offer a less invasive alternative to liver biopsies, providing reliable data to guide clinical decisions.
NAFLD is characterized by a proinflammatory and proatherogenic state that causes vascular inflammation and neurodegeneration, potentially leading to both clinical and subclinical cerebrovascular disease. Increasing epidemiological evidence links NAFLD to a higher risk and greater severity of stroke, independent of other vascular risk factors.Additionally, studies suggest NAFLD is involved in subclinical cerebrovascular diseases, such as carotid atherosclerosis which is characterized by the build-up of plaques in the carotid arteries. Patients with NAFLD exhibited greater carotid atherosclerosis .
- Conditions
- Fatty Liver, Acute Ischemic Cerebral Stroke
- Keywords
- Fatty liver, Acute ischemic cerebral stroke, Hepatic steatosis
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors
Measured: Baseline
Secondary outcomes (1)
Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gamal Atef El-sayed, Assiut University
- Investigators
- Mostafa A Gamal, Principal investigator, Assiut UniversityNoureldine A Abdelazeem, Study director, Assiut UniversityBahaa A Osman, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628700
- Sponsor's protocol ID
- Fatty liver
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
PubMed 3201508DeGraba TJ, Hallenbeck JM, Pettigrew KD, Dutka AJ, Kelly BJ. Progression in acute stroke: value of the initial NIH stroke scale score on patient stratification in future trials. Stroke. 1999 Jun;30(6):1208-12. doi: 10.1161/01.str.30.6.1208.
PubMed 10356101Mughal MM, Khan MK, DeMarco JK, Majid A, Shamoun F, Abela GS. Symptomatic and asymptomatic carotid artery plaque. Expert Rev Cardiovasc Ther. 2011 Oct;9(10):1315-30. doi: 10.1586/erc.11.120.
PubMed 21985544Tahmasebpour HR, Buckley AR, Cooperberg PL, Fix CH. Sonographic examination of the carotid arteries. Radiographics. 2005 Nov-Dec;25(6):1561-75. doi: 10.1148/rg.256045013.
PubMed 16284135
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden Fatty Liver Among Acute Ischemic Cerebral Stroke Patients
- ClinicalTrials.gov ID
- NCT06628700
- Acronym / sponsor ID
- Fatty liver
- Conditions
- Fatty Liver, Acute Ischemic Cerebral Stroke
- Keywords
- Fatty liver, Acute ischemic cerebral stroke, Hepatic steatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 8 Oct 2024 (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.
- Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors
- Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis .
Detailed description
Fatty liver disease, encompassing both alcoholic and non-alcoholic variants, is a growing health concern worldwide, with prevalence rates soaring in parallel with obesity and diabetes epidemics. The estimated global incidence of NAFLD alone is 47 cases per 1,000 people, with a higher rate observed in males than females. Among adults worldwide, the estimated prevalence of NAFLD is 32%, with a higher prevalence in males (40%) compared to females (26%), making it the most common liver disorder. The hazards of fatty liver disease extend beyond the liver itself .The condition is characterized by the accumulation of excess fat in liver cells, which can progress to more severe liver diseases, such as steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
Early assessment and diagnosis of liver steatosis are crucial for managing and mitigating the risks associated with FLD. Non-invasive methods, such as elastography combined with the Controlled Attenuation Parameter (CAP) score, have emerged as effective tools for detecting and quantifying liver fat content. These methods offer a less invasive alternative to liver biopsies, providing reliable data to guide clinical decisions.
NAFLD is characterized by a proinflammatory and proatherogenic state that causes vascular inflammation and neurodegeneration, potentially leading to both clinical and subclinical cerebrovascular disease. Increasing epidemiological evidence links NAFLD to a higher risk and greater severity of stroke, independent of other vascular risk factors.Additionally, studies suggest NAFLD is involved in subclinical cerebrovascular diseases, such as carotid atherosclerosis which is characterized by the build-up of plaques in the carotid arteries. Patients with NAFLD exhibited greater carotid atherosclerosis .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Days
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Newly diagnosed ischemic cerebral stroke patients exceeding of window phase without obvious risk factors.
Key inclusion criteria (3 listed)
- Newly diagnosed ischemic cerebral stroke exceeding of window phase without obvious risk factors.
- patients above 18 years.
- patients below 60 years.
Key exclusion criteria (4 listed)
- patients have obvious risk factors including: smoking, DM , Hypertension ,renal patients , cardiovascular diseases (AF , valvular disease ,reduced systolic function ,chronic HCV ,HBV).
- patients below 18 years.
- patients above 60 years.
- patients refused to contribute to this study.
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
Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors
Time frame: Baseline
1 secondary outcome
Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis .
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 3201508Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
- Results publication: PubMed 10356101DeGraba TJ, Hallenbeck JM, Pettigrew KD, Dutka AJ, Kelly BJ. Progression in acute stroke: value of the initial NIH stroke scale score on patient stratification in future trials. Stroke. 1999 Jun;30(6):1208-12. doi: 10.1161/01.str.30.6.1208.
- Results publication: PubMed 21985544Mughal MM, Khan MK, DeMarco JK, Majid A, Shamoun F, Abela GS. Symptomatic and asymptomatic carotid artery plaque. Expert Rev Cardiovasc Ther. 2011 Oct;9(10):1315-30. doi: 10.1586/erc.11.120.
- Results publication: PubMed 16284135Tahmasebpour HR, Buckley AR, Cooperberg PL, Fix CH. Sonographic examination of the carotid arteries. Radiographics. 2005 Nov-Dec;25(6):1561-75. doi: 10.1148/rg.256045013.
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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.
Mostafa A Gamal principal investigator
Assiut University
Noureldine A Abdelazeem study director
Assiut University
Bahaa A Osman study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Acute Ischemic Cerebral 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 3 inclusion and 4 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 8 Oct 2024. 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?
Contact Mostafa G Gamal (+20 1147731506, doctormga610@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628700, which also lists 4 linked publications.
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 8 Oct 2024.