MPV as a Predictor for ACS in Patients With MASLD (MPV/ACS MASLD)

April 30, 2026 updated by: Mariam Adeeb Samy, Sohag University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group I: MASLD patients with acute coronary syndrome (ACS).
Group II: MASLD patients without acute coronary syndrome

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At hospital admission / baseline assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Usama Ahmed Arafa, MD, unaffillated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-26-2-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to privacy and confidentiality considerations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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