Coronary Artery DiseaseNCT07149883
Evaluation of Mean Platelet Volume and Systemic Inflammatory Response Index (SIRI) in Patients of Acute Coronary Syndrome
An observational study of Coronary Artery Disease, run by Assiut University.
Trial summary
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Complete blood count and ECHO
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 20 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute coronary syndrome (ACS), which includes unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI), is a leading cause of hospitalization and death globally【1】. The pathophysiology of ACS involves plaque rupture, platelet activation, thrombus formation, and a significant inflammatory component【2】. Early diagnosis and accurate risk stratification are critical for improving patient outcomes and guiding therapy. Mean Platelet Volume (MPV) is a simple, cost-effective parameter obtained from the complete blood count. It reflects platelet size and activity-larger platelets are more reactive and thrombogenic. Studies have demonstrated that MPV is elevated in patients with ACS and may correlate with infarct size and poor prognosis【3,4】. The systemic inflammatory response plays a pivotal role in the destabilization of atherosclerotic plaques. Recently, novel inflammatory indices such as the Systemic Inflammatory Response Index (SIRI)-
Who may be able to join
- Patients ≥ 18 years old.
- Diagnosed with acute coronary syndrome (unstable angina, NSTEMI, STEMI).
- Admission within 24 hours of symptom onset.
Who cannot join
- o Active infection or chronic inflammatory diseases.
- Known hematological disorders or malignancy.
- Chronic liver or renal failure.
- Recent surgery or trauma (< 1 month).
- Patients with rheumatic heart disease
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Asmaa Salama ahmed omar, Resident doctor contact
About this study
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA)
Read the detailed description
Acute coronary syndrome (ACS), which includes unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI), is a leading cause of hospitalization and death globally【1】. The pathophysiology of ACS involves plaque rupture, platelet activation, thrombus formation, and a significant inflammatory component【2】. Early diagnosis and accurate risk stratification are critical for improving patient outcomes and guiding therapy.
Mean Platelet Volume (MPV) is a simple, cost-effective parameter obtained from the complete blood count. It reflects platelet size and activity-larger platelets are more reactive and thrombogenic. Studies have demonstrated that MPV is elevated in patients with ACS and may correlate with infarct size and poor prognosis【3,4】.
The systemic inflammatory response plays a pivotal role in the destabilization of atherosclerotic plaques. Recently, novel inflammatory indices such as the Systemic Inflammatory Response Index (SIRI)-calculated as (neutrophil count × monocyte count) / lymphocyte count-have emerged as potential marker for cardiovascular risk. SIRI reflects the combined effect of pro-inflammatory and anti-inflammatory components of the immune system【5】. Elevated SIRI has been associated with adverse outcomes in various conditions, including stroke, cancer, and cardiovascular diseases【6,7】.
Despite the individual significance of MPV and SIRI, limited data are available on their combined utility in ACS patients. Evaluating both markers together may provide a more comprehensive picture of the thrombo-inflammatory state and help identify high-risk patients at admission, facilitating more personalized care【8】.
- Conditions
- Coronary Artery Disease
- Being tested
- Complete blood count, ECHO
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countOther
Complete blood count
ECHODevice
device that used to evaluate the cardiac function
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA)
Evaluation of mean platelet volume and systemic inflammatory response index (SIRI) in patients of acute coronary syndrome
Measured: Baseline
Secondary outcomes (1)
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA
Evaluation of mean platelet volume and systemic inflammatory response index (SIRI) in patients of acute coronary syndrome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa salama ahmed omar, Assiut University
- Investigators
- Ghada Hassan, Professor, Study director, Assuit university hospitalHanan Sharaf, Professor, Study director, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149883
- Sponsor's protocol ID
- MPV and SIRI in of ACS
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.
PubMed 12490960Anderson JL, Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017 May 25;376(21):2053-2064. doi: 10.1056/NEJMra1606915. No abstract available.
PubMed 28538121
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mean Platelet Volume and Systemic Inflammatory Response Index (SIRI) in Patients of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07149883
- Acronym / sponsor ID
- MPV and SIRI in of ACS
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 2 Sep 2025 (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.
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA)
Detailed description
Acute coronary syndrome (ACS), which includes unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI), is a leading cause of hospitalization and death globally【1】. The pathophysiology of ACS involves plaque rupture, platelet activation, thrombus formation, and a significant inflammatory component【2】. Early diagnosis and accurate risk stratification are critical for improving patient outcomes and guiding therapy.
Mean Platelet Volume (MPV) is a simple, cost-effective parameter obtained from the complete blood count. It reflects platelet size and activity-larger platelets are more reactive and thrombogenic. Studies have demonstrated that MPV is elevated in patients with ACS and may correlate with infarct size and poor prognosis【3,4】.
The systemic inflammatory response plays a pivotal role in the destabilization of atherosclerotic plaques. Recently, novel inflammatory indices such as the Systemic Inflammatory Response Index (SIRI)-calculated as (neutrophil count × monocyte count) / lymphocyte count-have emerged as potential marker for cardiovascular risk. SIRI reflects the combined effect of pro-inflammatory and anti-inflammatory components of the immune system【5】. Elevated SIRI has been associated with adverse outcomes in various conditions, including stroke, cancer, and cardiovascular diseases【6,7】.
Despite the individual significance of MPV and SIRI, limited data are available on their combined utility in ACS patients. Evaluating both markers together may provide a more comprehensive picture of the thrombo-inflammatory state and help identify high-risk patients at admission, facilitating more personalized care【8】.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome (ACS), which includes unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI), is a leading cause of hospitalization and death globally【1】. The pathophysiology of ACS involves plaque rupture, platelet activation, thrombus formation, and a significant inflammatory component【2】. Early diagnosis and accurate risk stratification are critical for improving patient outcomes and guiding therapy. Mean Platelet Volume (MPV) is a simple, cost-effective parameter obtained from the complete blood count. It reflects platelet size and activity-larger platelets are more reactive and thrombogenic. Studies have demonstrated that MPV is elevated in patients with ACS and may correlate with infarct size and poor prognosis【3,4】. The systemic inflammatory response plays a pivotal role in the destabilization of atherosclerotic plaques. Recently, novel inflammatory indices such as the Systemic Inflammatory Response Index (SIRI)-
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old.
Key exclusion criteria (6 listed)
- o Active infection or chronic inflammatory diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countComplete blood count | Other | – |
| ECHOdevice that used to evaluate the cardiac function | Device | – |
Primary outcome
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA)
Time frame: Baseline
Evaluation of mean platelet volume and systemic inflammatory response index (SIRI) in patients of acute coronary syndrome
1 secondary outcome
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA
Time frame: Baseline
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 2 Sep 2025.
- Results publication: PubMed 12490960Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.
- Results publication: PubMed 28538121Anderson JL, Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017 May 25;376(21):2053-2064. doi: 10.1056/NEJMra1606915. No abstract available.
- Individual participant dataSharing planned: No
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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.
Asmaa Salama ahmed omar, Resident doctor contact
Ghada Hassan, Professor study director
Assuit university hospital
Hanan Sharaf, Professor study director
Assuit university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, 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 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 2 Sep 2025. 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?
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 Asmaa Salama ahmed omar, Resident doctor (+01067687469 ext. 01006876891, asmaasalamaahmed4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the diagnostic and prognostic significance of MPV and SIRI in patients presenting with acute coronary syndrome.(STEMI/NSTEMI/UN STABLE ANGINA) (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 NCT07149883, which also lists 2 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 2 Sep 2025.