STEMI - ST Elevation Myocardial InfarctionNCT03267199
The Relationship Between MPV,PDW,PFT and ST Segment Resolution in STEMI Patients Treated With Thrombolytic or Primary PCI
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Assiut University.
Trial summary
The relationship between admission MPV, PDW, platelet function test and ST-segment resolution in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention The relationship between admission MPV, PDW, platelet function test and high thrombus burden \& post-PCI Thrombolysis In… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Thrombolytic, Primary PCI and Complete blood count
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with STEMI presented who will be treated with either thrombolytic therapy or primary PCI in assiut university cath lab will be included in the study
Who may be able to join
- patients with STEMI presented who will be treated with either thrombolytic therapy or primary PCI in assiut university cath lab will be included in the study
Who cannot join
- Patient with complete LBBB on admission ECG
- Active infection
- Documented systemic inflammatory disease
- Malignancy
- End-stage liver
- Renal failure
- Patient receiving oral anticoagulation medicine
- Bleeding diathesis
About this study
Official title: The Relationship Between Mean Platelet Volume , Platelet Distribution Width , Platelet Function and ST Segment Resolution in STEMI Patients Treated With Either Thrombolytic Therapy or Primary Percutaneous Coronary Intervention
- The relationship between admission MPV, PDW, platelet function test and ST-segment resolution in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention
- The relationship between admission MPV, PDW, platelet function test and high thrombus burden \& post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
Read the detailed description
Reperfusion therapy as the main treatment strategy in patients with ST-segment elevation myocardial infarction (STEMI) consists of either thrombolysis or primary percutaneous coronary intervention (pPCI). Primary percutaneous coronary intervention is the preferred therapy for STEMI; however, cardiac catheterization laboratories may not be widely available.
Early recanalization of the infarct related artery (IRA) by either thrombolytics or percutaneous coronary intervention (PCI) is the main goal in the treatment of acute myocardial infarction. But the eventual aim is to provide reperfusion at the tissue level as well as in the infarct related artery .
Resolution of ST elevation has been shown as an agreeable marker that reflects both epicardial and myocardial reperfusion . In addition, early and complete resolution of ST -segment in the setting of acute myocardial infarction is associated with smaller infarct size, greater ejection fraction and reduced morbidity and mortality .
Platelets play a critical role in the pathogenesis and prognosis of ACS . They secrete a number of substances that are key mediators of coagulation, thrombosis and atherosclerosis. High-volume platelets have a higher thrombotic potential than small platelets and have concentrated granule contents that are of interest in the development of ACS pathogenesis . Mean platelet volume (MPV) is the most commonly used measure of platelet size and correlates with platelet activity. Platelet distribution width (PDW) is an index reflecting heterogeneous platelet size, whereas the platelet-large cell ratio (P-LCR) is the proportion of large platelets in blood circulation. Generally, higher MPV, PDW and P-LCR are correlated with increased platelet size, although they tend to be overlooked in clinical applications. In fact, these indices, particularly MPV and PDW, correlate with platelet functions.
Percutaneous coronary intervention (PCI) is an effective treatment for acute coronary syndrome (ACS), including ST-elevation myocardial infarction (STEMI) and unstable angina. Despite the efficacy of the technique, preprocedural high-thrombus burden (HTB) is a predictor of procedural complications following primary PCI for STEMI. HTB can lead to poor outcomes, including distal embolization, no-reflow, increased myocardial necrosis and decreased left ventricular function.
Although MPV is associated with impaired angiographic reperfusion and poor clinical outcome in patients with STEMI,little is known regarding the association between MPV levels and infarct related artery patency in those patients.
- Being tested
- Thrombolytic, Primary PCI, Complete blood count, Platelet function test, ECG
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombolyticDrug
Thrombolytic therapy
Primary PCIProcedure or surgery
Primary percutaneous coronary intervention
Complete blood countDiagnostic test
Blood sample for complete blood count
Platelet function testDiagnostic test
Blood sample for platelet function test
ECGDiagnostic test
Electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| patients with high MPV,PDW,PFT | patients with high MPV,PDW,platelet function test Receives: Drug: Thrombolytic; Procedure: Primary PCI; Diagnostic Test: Complete blood count; Diagnostic Test: Platelet function test; Diagnostic Test: ECG | |
| patients with normal or low MPV,PDW, PFT | patients with normal or low MPV,PDW,platelet function test Receives: Drug: Thrombolytic; Procedure: Primary PCI; Diagnostic Test: Complete blood count; Diagnostic Test: Platelet function test; Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients assessed by CBC ,platelet function test & ECG
Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention assessed by CBC,platelet function test \& ECG
Measured: Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI
Secondary outcomes (2)
Correlation between MPV,PDW,platelet function test and TIMI flow of infarct related artery in STEMI patients treated with primary PCI
Correlation between MPV ,PDW,platelet function test and post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
Measured: Baseline
Correlation between MPV,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary PCI
Correlation between MPV ,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Another study was done instead
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardeen Beshay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267199
- Sponsor's protocol ID
- 17100302
- Status last verified
- Feb 2023
- First submitted
- 25 Aug 2017
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Mean Platelet Volume , Platelet Distribution Width , Platelet Function and ST Segment Resolution in STEMI Patients Treated With Either Thrombolytic Therapy or Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03267199
- Acronym / sponsor ID
- 17100302
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Another study was done instead
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 30 Aug 2017 (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 relationship between admission MPV, PDW, platelet function test and ST-segment resolution in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention
- The relationship between admission MPV, PDW, platelet function test and high thrombus burden \& post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
Detailed description
Reperfusion therapy as the main treatment strategy in patients with ST-segment elevation myocardial infarction (STEMI) consists of either thrombolysis or primary percutaneous coronary intervention (pPCI). Primary percutaneous coronary intervention is the preferred therapy for STEMI; however, cardiac catheterization laboratories may not be widely available.
Early recanalization of the infarct related artery (IRA) by either thrombolytics or percutaneous coronary intervention (PCI) is the main goal in the treatment of acute myocardial infarction. But the eventual aim is to provide reperfusion at the tissue level as well as in the infarct related artery .
Resolution of ST elevation has been shown as an agreeable marker that reflects both epicardial and myocardial reperfusion . In addition, early and complete resolution of ST -segment in the setting of acute myocardial infarction is associated with smaller infarct size, greater ejection fraction and reduced morbidity and mortality .
Platelets play a critical role in the pathogenesis and prognosis of ACS . They secrete a number of substances that are key mediators of coagulation, thrombosis and atherosclerosis. High-volume platelets have a higher thrombotic potential than small platelets and have concentrated granule contents that are of interest in the development of ACS pathogenesis . Mean platelet volume (MPV) is the most commonly used measure of platelet size and correlates with platelet activity. Platelet distribution width (PDW) is an index reflecting heterogeneous platelet size, whereas the platelet-large cell ratio (P-LCR) is the proportion of large platelets in blood circulation. Generally, higher MPV, PDW and P-LCR are correlated with increased platelet size, although they tend to be overlooked in clinical applications. In fact, these indices, particularly MPV and PDW, correlate with platelet functions.
Percutaneous coronary intervention (PCI) is an effective treatment for acute coronary syndrome (ACS), including ST-elevation myocardial infarction (STEMI) and unstable angina. Despite the efficacy of the technique, preprocedural high-thrombus burden (HTB) is a predictor of procedural complications following primary PCI for STEMI. HTB can lead to poor outcomes, including distal embolization, no-reflow, increased myocardial necrosis and decreased left ventricular function.
Although MPV is associated with impaired angiographic reperfusion and poor clinical outcome in patients with STEMI,little is known regarding the association between MPV levels and infarct related artery patency in those patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with high MPV,PDW,PFT | – | Drug: Thrombolytic, Procedure: Primary PCI, Diagnostic Test: Complete blood count, Diagnostic Test: Platelet function test, Diagnostic Test: ECGpatients with high MPV,PDW,platelet function test |
| patients with normal or low MPV,PDW, PFT | – | Drug: Thrombolytic, Procedure: Primary PCI, Diagnostic Test: Complete blood count, Diagnostic Test: Platelet function test, Diagnostic Test: ECGpatients with normal or low MPV,PDW,platelet function test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with STEMI presented who will be treated with either thrombolytic therapy or primary PCI in assiut university cath lab will be included in the study
Key inclusion criteria (1 listed)
- patients with STEMI presented who will be treated with either thrombolytic therapy or primary PCI in assiut university cath lab will be included in the study
Key exclusion criteria (8 listed)
- Patient with complete LBBB on admission ECG
- Active infection
- Documented systemic inflammatory disease
- Malignancy
- End-stage liver
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 |
|---|---|---|
| ThrombolyticThrombolytic therapy | Drug | patients with high MPV,PDW,PFT, patients with normal or low MPV,PDW, PFT |
| Primary PCIPrimary percutaneous coronary intervention | Procedure or surgery | patients with high MPV,PDW,PFT, patients with normal or low MPV,PDW, PFT |
| Complete blood countBlood sample for complete blood count | Diagnostic test | patients with high MPV,PDW,PFT, patients with normal or low MPV,PDW, PFT |
| Platelet function testBlood sample for platelet function test | Diagnostic test | patients with high MPV,PDW,PFT, patients with normal or low MPV,PDW, PFT |
| ECGElectrocardiogram | Diagnostic test | patients with high MPV,PDW,PFT, patients with normal or low MPV,PDW, PFT |
Primary outcome
Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients assessed by CBC ,platelet function test & ECG
Time frame: Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI
Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention assessed by CBC,platelet function test \& ECG
2 secondary outcomes
Correlation between MPV,PDW,platelet function test and TIMI flow of infarct related artery in STEMI patients treated with primary PCI
Time frame: Baseline
Correlation between MPV,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary PCI
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction, 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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Feb 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients assessed by CBC ,platelet function test & ECG (time frame: Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI). 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 3 Feb 2023.