NCT03476252

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 12, 2018

Last Update Submit

March 25, 2018

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients

EXPERIMENTAL

ST elevation myocardial infarction

Diagnostic Test: pentraxin 3

Interventions

pentraxin 3DIAGNOSTIC_TEST

serum pentraxin 3 level will be assessed using ELISA kits

patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.1371/journal.pone.0031474. Epub 2012 Feb 3.

    PMID: 22319633RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Salwa Roshdy, MD

CONTACT

01223971267salwademitry@aun.edu.eg

Heba Mahmoud, MD

CONTACT

01001963100heba_m_elnaggar@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Stemi group undergoing primary pci
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiology resident, principal investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 26, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2020

Last Updated

March 27, 2018

Record last verified: 2018-03