Relation of Laboratory Indices to Left Ventricular Thrombus Formation in Patients With Acute Anterior ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention or Thrombolytic Therapy

November 29, 2023 updated by: Al zahraa Sayed Mahmoud Mohamed, Assiut University
• to find the relationship between the different hematological indices including platelet indices, and blood cell ratios, to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) , or thrombolytic therapy .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

ST-segment elevation myocardial infarction (STEMI) has been associated with a high rate of morbidity and mortality (1) Left ventricular thrombus (LVT), one of the most common complications of acute anterior myocardial infarction is linked to the potentially devastating outcome of thromboembolism or stroke [1, 2] , In the era of primary PCI, despite aggressive reperfusion treatment and antithrombotic treatment, the presence of LVT remains high after anterior STEMI), Determining the correlation between clinical and laboratory indicators of thrombosis is the key to the prevention of thromboembolism , The PLR( platelets to lymphocytes ratio ), a new index , provides information about both the inflammatory and thrombosis pathways(3), It is known since long that larger platelets are metabolically and enzymatically more active than small platelets and they have higher thrombotic potentials , that is why MPV , Platelets count , and platelet crit (PCT) are related to platelets activation and they have been suggested as markers of haemostasis , Increase MPV is thought to be associated with thrombus formation in all vascular structures , Recent evidence has shown the meaningful clinical information of the PLR in coronary heart disease and thrombotic diseases (whether diagnostic information or prognostic information). Despite the findings above, data regarding the role of this inflammatory biomarker in LVT are lacking. We conducte a prospective case-control study to explore the correlation between LVT and the PLR and different hematologic indices among anterior STEMI patients with LV dysfunction after primary PCI, or thromolytic therapy, Hematological markers, predictive and even diagnostic value in cardiovascular diseases (CVDs) is a major field of research (4) Leukocytes are considered essential for thrombus formation as well as plaque activation in acute coronary syndrome (ACS). The most reliable indicator of unfavorable outcomes has been proven to be platelet count and may platelet volume, haematocrit, haemoglobin, peak level Troponin and CK-MB (5), Monocytes play a critical role in atherosclerosis by releasing cytokines that are pro-inflammatory and pro-oxidant (6) High values of the monocyte are associated with unfavourable outcomes and severe coronary artery disease (7) ). So, we aimed to find relationship between the different hematological indices and LV thrombus formation in anterior STEMI managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy.

Study Type

Observational

Enrollment (Estimated)

400

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 Backup

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients present with acute anterior STEMI and undergoing primary percutaneous coronary intervention or thrombolytic therapy in Assiut university heart hospital (AUHH). Patients will be categorized into 2 groups: those with LVT and those without LVT development.

Description

Inclusion Criteria:

  • All patients presented to Assiut university cardiac catheterization laboratory with acute anterior STEMI and managed with PPCI or thrombolytic therapy.

Exclusion Criteria:

  • • Patients not eligible to PPCI

    • Patients presented with inferior or lateral STEMI or any type of STEMI other than anterior STEMI.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients with acute anterior ST segment elevation myocardial infarction undergoing primary percutaneous coronary intervention .
Other: Primary percutaneous coronary intervention or thrombolytic therapy
Primary percutaneous coronary intervention or thrombolytic therapy
2
patients with acute anterior ST segment elevation myocardial infarction have thrombolytic therapy .
Other: Primary percutaneous coronary intervention or thrombolytic therapy
Primary percutaneous coronary intervention or thrombolytic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the relation of different hematological indices to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
Time Frame: baseline
• To assess the relation of different hematological indices including platelet indices: Mean platelet volume (MPV), Mean platelet component (MPC) , Plateletcrit (PCT), platelet distribution width (PDW), Mean platelet mass (MPM), and blood cell ratios: Neutrophil to lymphocyte ratio (NLR), Platelet to lymphocyte ratio (PLR),White blood cell to Mean platelet volume (WMR) to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) or thrombolytic therapy .
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o Assessment of protein C, S, and activated protein C resistance (APCR) and its relation to LVT development.
Time Frame: baseline
  • Assessment of protein C, S, and activated protein C resistance (APCR) and its relation to LVT development.
  • Relation of the former indices to intracoronary thrombus burden
  • Relation of the former indices to major adverse cardiac and cerebrovascular events (MACCEs), both in-hospital and at 3 months
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Estimated)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LV thrombus in anterior STEMI

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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