- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487571
MPV as a Predictor for ACS in Patients With MASLD (MPV/ACS MASLD)
Mean Platelet Volume as a Predictor for Acute Coronary Syndrome in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
Study Overview
Status
Detailed Description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a growing global health concern closely linked to metabolic syndrome, obesity, insulin resistance, and cardiovascular disease. Patients with MASLD have an increased risk of atherosclerosis and acute coronary syndrome (ACS), which remains a leading cause of morbidity and mortality worldwide. Early identification of patients at high cardiovascular risk is essential to improve outcomes.
Mean platelet volume (MPV) is an accessible and cost-effective hematological parameter that reflects platelet size and activity. Larger platelets are metabolically and enzymatically more active and have greater prothrombotic potential. Elevated MPV has been associated with increased platelet reactivity, endothelial dysfunction, and adverse cardiovascular events, including ACS. However, the predictive value of MPV for ACS in patients with MASLD has not been sufficiently investigated.
This study aims to evaluate MPV as a predictor of acute coronary syndrome in patients diagnosed with MASLD at Sohag University Hospital. By assessing the relationship between MPV levels and the occurrence of ACS, the study seeks to determine whether MPV can serve as a simple, noninvasive biomarker for cardiovascular risk stratification in this high-risk population.
The study will include patients with confirmed MASLD, who will undergo clinical evaluation, laboratory investigations including complete blood count for MPV measurement, and cardiovascular assessment. Participants will be categorized based on the presence or absence of ACS. Statistical analyses will be performed to evaluate the association between MPV and ACS and to determine its predictive value.
The findings of this study may contribute to improved risk assessment strategies and early identification of MASLD patients at increased risk for acute coronary events, potentially guiding preventive and therapeutic interventions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mariam Adeeb Samy, Resident
- Phone Number: 01202515622
- Email: mariam_adeeb_post@med.sohag.edu.eg
Study Locations
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Sohag Governorate
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Sohag, Sohag Governorate, Egypt
- Sohag University Hospital
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Contact:
- Mariam Adeeb Samy, Resident
- Phone Number: 01202515622
- Email: mariam_adeeb_post@med.sohag.edu.eg
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Contact:
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Principal Investigator:
- Mariam Adeeb Samy, Resident
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who are admitted to or evaluated at Sohag University Hospital. Eligible participants will include patients with confirmed MASLD based on clinical evaluation, laboratory findings, and imaging studies. The study will include two groups: patients with MASLD who present with acute coronary syndrome (ACS) and patients with MASLD without evidence of ACS.
Participants will be recruited from inpatient and outpatient services, including the cardiology and internal medicine departments. Demographic and clinical data, cardiovascular risk factors, and laboratory parameters-including mean platelet volume (MPV)-will be collected at baseline
Description
Inclusion Criteria:
- Adult patients aged ≥18 years.
- Confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) based on clinical, laboratory, and imaging criteria).
- Patients diagnosed with acute coronary syndrome (unstable angina, NSTEMI, or STEMI) for Group I.
- MASLD patients without clinical or electrocardiographic evidence of acute coronary syndrome for Group II.
- Patients who provide informed consent to participate in the study.
Exclusion Criteria:
- Patients with chronic liver diseases other than MASLD (e.g., viral hepatitis, autoimmune hepatitis, alcoholic liver disease).
- Patients with known hematological disorders affecting platelet count or function.
- Patients receiving antiplatelet or anticoagulant therapy prior to blood sampling.
- Patients with active infection, inflammatory diseases, or malignancy.
- Patients with chronic kidney disease or end-stage renal failure.
- Pregnant or lactating females.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group I: MASLD patients with acute coronary syndrome (ACS).
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Group II: MASLD patients without acute coronary syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean platelet volume as a predictor for acute coronary syndrome in patients with metabolic dysfunction-associated steatotic liver disease
Time Frame: At hospital admission / baseline assessment.
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To evaluate the association between mean platelet volume (MPV) levels and the presence of acute coronary syndrome in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
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At hospital admission / baseline assessment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Usama Ahmed Arafa, MD, unaffillated
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-2-10MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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