The Relationship Between MPV,PDW,PFT and ST Segment Resolution in STEMI Patients Treated With Thrombolytic or Primary PCI

February 8, 2019 updated by: Nardeen Beshay, Assiut University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 (Anticipated)

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.
200

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.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with high MPV,PDW,PFT
patients with high MPV,PDW,platelet function test
Drug: Thrombolytic
Thrombolytic therapy
Procedure: Primary PCI
Primary percutaneous coronary intervention
Diagnostic test: Complete blood count
Blood sample for complete blood count
Diagnostic test: Platelet function test
Blood sample for platelet function test
Diagnostic test: ECG
Electrocardiogram
patients with normal or low MPV,PDW, PFT
patients with normal or low MPV,PDW,platelet function test
Drug: Thrombolytic
Thrombolytic therapy
Procedure: Primary PCI
Primary percutaneous coronary intervention
Diagnostic test: Complete blood count
Blood sample for complete blood count
Diagnostic test: Platelet function test
Blood sample for platelet function test
Diagnostic test: ECG
Electrocardiogram

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
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
Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
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
Correlation between MPV ,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
Baseline

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.
Assiut University

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 (Anticipated)

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.
December 1, 2020

Primary Completion (Anticipated)

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.
December 1, 2020

Study Completion (Anticipated)

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.
August 1, 2021

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).
August 25, 2017

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.
August 29, 2017

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.
August 30, 2017

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.
February 12, 2019

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.
February 8, 2019

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.
August 1, 2018

More Information

Terms related to this study

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.
  • 17100302

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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