Diagnostic and Prognostic Utility of Pentraxin 3 in Patients With Acute STEMI Undergoing Primary PCI

March 25, 2018 updated by: Mina maher hafez, Assiut University

Diagnostic and Prognostic Utility of Pentraxin 3 in Patients With Acute ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

A number of inflammatory markers have been recognized, among which the acute phase reactant C-reactive protein showed a positive correlation with the risk of coronary artery disease in both healthy individuals and those at high risk .

Pentraxin 3 is expressed in atherosclerotic plaques, mainly in macrophages and neutrophils, suggesting that pentraxin 3 may be involved in the progression of atherosclerotic plaque.

  • A number of studies demonstrated that increased levels of Pentraxin 3 were associated with the presence and increased severity of coronary artery disease in clinically stable patients undergoing elective coronary angiography .
  • Pentraxin 3 levels peak at about 7 h after acute MI, which is substantially earlier than CRP, and thus PTX3 could be a better independent predictor of CHD than CRP .
  • Recently, it was shown that the number of the involved vessels, MI type, stent length, culprit lesion, and the need for PCI all had a significant relation with abnormal Pentraxin 3 levels , however, it was not studied with respect of its relation with postprocedural angiographic and clinical outcomes.

We thought to evaluate the role of pentraxin-3 on the preprocedural determinants (Grace score, type of MI, culprit lesion, lesion length, pre-procedural TIMI flow, thrombus burden, severity and complexity of CAD as determined by Syntax score and procedural outcome (post-procedural TIMI flow, no reflow and myocardial perfusion assessed by myocardial blush grade as well as the inhospital clinical outcome of primary Percutaneous coronary intervention in patients with acute ST elevation myocardial infarction.

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

A number of inflammatory markers have been recognized, among which the acute phase reactant C-reactive protein showed a positive correlation with the risk of coronary artery disease in both healthy individuals and those at high risk .

Pentraxin 3 is expressed in atherosclerotic plaques, mainly in macrophages and neutrophils, suggesting that pentraxin 3 may be involved in the progression of atherosclerotic plaque.

  • A number of studies demonstrated that increased levels of Pentraxin 3 were associated with the presence and increased severity of coronary artery disease in clinically stable patients undergoing elective coronary angiography .
  • Pentraxin 3 levels peak at about 7 h after acute MI, which is substantially earlier than CRP, and thus PTX3 could be a better independent predictor of CHD than CRP .
  • Recently, it was shown that the number of the involved vessels, MI type, stent length, culprit lesion, and the need for PCI all had a significant relation with abnormal Pentraxin 3 levels , however, it was not studied with respect of its relation with postprocedural angiographic and clinical outcomes.

We thought to evaluate the role of pentraxin-3 on the preprocedural determinants (Grace score, type of MI, culprit lesion, lesion length, pre-procedural TIMI flow, thrombus burden, severity and complexity of CAD as determined by Syntax score and procedural outcome (post-procedural TIMI flow, no reflow and myocardial perfusion assessed by myocardial blush grade as well as the inhospital clinical outcome of primary Percutaneous coronary intervention in patients with acute ST elevation myocardial infarction.

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.
Interventional

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.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Patients presenting to our CCU with acute myocardial infarction (STEMI) undergoing PPCI: chest pain > 30 minutes and ST segment elevation in more than one lead, include the definition of MI with a reference: Third universal definition of MI.

Exclusion Criteria:

  1. Patients complicated with an infectious disease on admission, active systemic inflammatory disease or chronic inflammatory disease(systemic lupus ,rheumatoid arthritis ,etc).
  2. Immune system disease or glucocorticoid therapy.
  3. Patients with history of cancer
  4. Patients of chronic kidney disease
  5. Patients on regular treatments with statins
  6. Patients of valvular heart disease, atrial fibrillation (positive relation was proved by previous studies), heart failure and/or cardiogenic shock.
  7. Patients underwent previous elective pci or previous CABG.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: patients
ST elevation myocardial infarction
Diagnostic test: pentraxin 3
serum pentraxin 3 level will be assessed using ELISA kits

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
Measuring relation between pentraxin 3 level and severity of coronary artery disease
Time Frame: two years
Number of st elevation patients will be investigated before primary percutaneous coronary intervention by measuring serum pentraxin 3 level aiming for good clinical short term outcomes
two years

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.

General Publications

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.
November 1, 2018

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.
November 1, 2019

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.
November 1, 2020

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).
March 12, 2018

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.
March 22, 2018

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.
March 26, 2018

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.
March 27, 2018

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.
March 25, 2018

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.
March 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.
  • PTX3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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