Diagnostic and Prognostic Utility of Pentraxin 3 in Patie... | NCT03476252

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

NCT03476252

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 27, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Myocardial Infarction

Interventions

pentraxin 3

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2018Estimated

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2020Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Mar 22, 2018

First Posted Date

Mar 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2018

Last Update Posted Date

Mar 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients	Experimental	ST elevation myocardial infarction	Diagnostic Test: pentraxin 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pentraxin 3	Diagnostic Test	serum pentraxin 3 level will be assessed using ELISA kits	patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring relation between pentraxin 3 level and severity of coronary artery disease	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salwa Roshdy, MD	Contact	01223971267		salwademitry@aun.edu.eg
Heba Mahmoud, MD	Contact	01001963100		heba_m_elnaggar@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22319633	Result	Knoflach M, Kiechl S, Mantovani A, Cuccovillo I, Bottazzi B, Xu Q, Xiao Q, Gasperi A, Mayr A, Kehrer M, Willeit J, Wick G. Pentraxin-3 as a marker of advanced atherosclerosis results from the Bruneck, ARMY and ARFY Studies. PLoS One. 2012;7(2):e31474. doi: 10.1371/journal.pone.0031474. Epub 2012 Feb 3.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases