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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

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 (Estimated)

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.
400

Contacts and Locations

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Study Contact

Study Contact

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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

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

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

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.
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

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
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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Study Major Dates

Study Start (Estimated)

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.
January 1, 2024

Primary Completion (Estimated)

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.
November 1, 2024

Study Completion (Estimated)

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.
December 1, 2024

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).
September 19, 2023

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.
November 29, 2023

First Posted (Estimated)

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.
December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
December 1, 2023

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.
November 29, 2023

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.
November 1, 2023

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.
  • 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

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