Metabolic Dysfunction-Associated Steatotic Liver DiseaseMPV/ACS MASLDNCT07487571
MPV as a Predictor for ACS in Patients With MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Acute Coronary Syndromes (ACS), run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Acute Coronary Syndromes (ACS)
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate
Mariam Adeeb Samy, Resident, 01202515622, mariam_adeeb_post@med.sohag.edu.eg
mariam_adeeb_post@med.sohag.edu.eg
About this study
Official title: Mean Platelet Volume as a Predictor for Acute Coronary Syndrome in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
The aim of this study is to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Sohag University Hospital.
Read the 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.
- Keywords
- Mean platelet volume, Cardiovascular risk, Platelet activation, Metabolic syndrome, Liver staetosis
- Medical subject headings
- Acute Coronary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I: MASLD patients with acute coronary syndrome (ACS). | Not described | |
| Group II: MASLD patients without acute coronary syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean platelet volume as a predictor for acute coronary syndrome in patients with metabolic dysfunction-associated steatotic liver disease
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).
Measured: At hospital admission / baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start5 May 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Adeeb Samy, Sohag University
- Investigators
- Usama Ahmed Arafa, MD, Principal investigator, unaffillated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487571
- Sponsor's protocol ID
- Soh-Med-26-2-10MS
- Acronym
- MPV/ACS MASLD
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Platelet Volume as a Predictor for Acute Coronary Syndrome in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07487571
- Acronym / sponsor ID
- MPV/ACS MASLD / Soh-Med-26-2-10MS
- Keywords
- Mean platelet volume, Cardiovascular risk, Platelet activation, Metabolic syndrome, Liver staetosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
The aim of this study is to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD to evaluate mean platelet volume (MPV) as a predictor of acute coronary syndrome (ACS) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Sohag University Hospital.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: MASLD patients with acute coronary syndrome (ACS). | – | – |
| Group II: MASLD patients without acute coronary syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality considerations
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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.
Usama Ahmed Arafa, MD principal investigator
unaffillated
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 Metabolic Dysfunction-Associated Steatotic Liver Disease and Acute Coronary Syndromes (ACS), run by Sohag 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Adeeb Samy, Resident (01202515622, mariam_adeeb_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 6 May 2026.