Myocardial InfarctionNCT03476252
Diagnostic and Prognostic Utility of Pentraxin 3 in Patients With Acute STEMI Undergoing Primary PCI
A study testing pentraxin 3 in people with Myocardial Infarction, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- pentraxin 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
- 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- pentraxin 3
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentraxin 3Diagnostic test
serum pentraxin 3 level will be assessed using ELISA kits
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | ST elevation myocardial infarction Receives: Diagnostic Test: pentraxin 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stemi group undergoing primary pci
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina maher hafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476252
- Sponsor's protocol ID
- PTX3
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22319633
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Utility of Pentraxin 3 in Patients With Acute ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03476252
- Acronym / sponsor ID
- PTX3
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stemi group undergoing primary pci
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Diagnostic Test: pentraxin 3ST elevation myocardial infarction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentraxin 3serum pentraxin 3 level will be assessed using ELISA kits | Diagnostic test | patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Results publication: PubMed 22319633Knoflach 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing pentraxin 3 in people with Myocardial Infarction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salwa Roshdy, MD (01223971267, salwademitry@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring relation between pentraxin 3 level and severity of coronary artery disease (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.