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WithdrawnNCT03267199Updated Feb 3, 2023

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

An observational study in STEMI - ST Elevation Myocardial Infarction, sponsored by Assiut University. Withdrawn. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by Assiut University · Observational

Why this study was withdrawn
Another study was done instead
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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 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.

02

Conditions studied

  • STEMI - ST Elevation Myocardial Infarction
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with high MPV,PDW,PFT

    patients with high MPV,PDW,platelet function test

    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

    Drug: Thrombolytic · Procedure: Primary PCI · Diagnostic Test: Complete blood count · Diagnostic Test: Platelet function test · Diagnostic Test: ECG

Interventions

  • DrugThrombolytic

    Thrombolytic therapy

  • ProcedurePrimary PCI

    Primary percutaneous coronary intervention

  • Diagnostic testComplete blood count

    Blood sample for complete blood count

  • Diagnostic testPlatelet function test

    Blood sample for platelet function test

  • Diagnostic testECG

    Electrocardiogram

05

What researchers measure

Primary outcomes

  1. 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

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

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03267199
Lead sponsor
Assiut University
Responsible party
Nardeen Beshay (resident physician, Assiut University) — Principal investigator
First posted
Aug 30, 2017
Start date
Dec 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Aug 2021 (estimated)
Last update
Feb 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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