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

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: Unknown
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Thrombolytic; Procedure: Primary PCI; Diagnostic test: Complete blood count; Diagnostic test: Platelet function test; Diagnostic test: ECG

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: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Nardeen Beshay; Phone Number: 00+20 201014812079; Email: nardeen.beshay@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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	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

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	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	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

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents
• Other Study ID 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