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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03476252
• Other study ID #: PTX3
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2018
• Last updated: March 25, 2018
• Start date: November 2018
• Est. completion date: November 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Salwa Roshdy, MD
• Phone: 01223971267
• Email: salwademitry[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Diagnostic Test:
• pentraxin 3
serum pentraxin 3 level will be assessed using ELISA kits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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