STEMINCT06491667
NLR AND CRP Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
An observational study of STEMI, run by Sohag University at 1 site in Egypt.
Trial summary
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide. Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- STEMI
- What is being tested?
- CBC and C-reactive protein
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI
Who may be able to join
- Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI.
Who cannot join
- Patients presenting with NSTEMI and unstable angina
- Patients with any of these associated conditions that can affect NLR or CRP including
- Inflammatory conditions such as collagen-vascular disorders
- Acute or chronic infectious diseases.
- Auto-immune and neoplastic diseases.
- Chronic hepatic diseases.
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- Renal failure.
- Thyroid disorders.
- Previous valvular heart disease.
Trial locations and contacts
1 site in 1 country.
Sharaf El-DEEN Sh Abd-Allah, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
Official title: Neutrophil-to-Lymphocyte Ratio AND C-REATIVE PROTEIN Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.
Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques.
Read more
Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI).
, and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .
Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world .
The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ; has emerged as an important inflammatory markers for cardiovascular risk stratification.
And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes
Read the detailed description
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.
- Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease
- It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques
- Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) . , and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .
- Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world
- The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ;
- has emerged as an important inflammatory markers for cardiovascular risk stratification.
- And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes In patients with acute myocardial infarction.
- Recent data indicates a strong independent relationship between increased complications after acute myocardial infarction in patients with a high NLR and high CRP level at admission and the initial post-hospitalization period.
- Accordingly, we designed this study to assess the predictive value and prognosis of NLR and CRP in ST-elevation myocardial infarction (STEMI).
- Conditions
- STEMI
- Being tested
- CBC, C-reactive protein
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCDiagnostic test
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
C-reactive proteinDiagnostic test
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Elevated NLR and CRP level | Elevated NLR and CRP level Receives: Diagnostic Test: CBC; Diagnostic Test: C-reactive protein | |
| Normal NLR and CRP level | Elevated NLR and CRP level Receives: Diagnostic Test: CBC; Diagnostic Test: C-reactive protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-lymphocyte ratio
Explore the role of Neutrophil-lymphocyte ratio in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
Measured: 6 months
C-reactive protein
C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albier Youssef Kaiser, Sohag University
- Investigators
- Magdy M Amin, Professor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491667
- Sponsor's protocol ID
- Soh-med-24-0614MS
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gualandro DM, Caramelli B, Yu PC, Marques AC, Calderaro D. Perioperative myocardial infarction has been forgotten. J Am Coll Cardiol. 2008 May 6;51(18):1825-6; author reply 1826. doi: 10.1016/j.jacc.2008.01.035. No abstract available.
PubMed 18452792Sahoo S, Losordo DW. Exosomes and cardiac repair after myocardial infarction. Circ Res. 2014 Jan 17;114(2):333-44. doi: 10.1161/CIRCRESAHA.114.300639.
PubMed 24436429Kuklina EV, Yoon PW, Keenan NL. Prevalence of coronary heart disease risk factors and screening for high cholesterol levels among young adults, United States, 1999-2006. Ann Fam Med. 2010 Jul-Aug;8(4):327-33. doi: 10.1370/afm.1137.
PubMed 20644187Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
PubMed 11877368
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-to-Lymphocyte Ratio AND C-REATIVE PROTEIN Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06491667
- Acronym / sponsor ID
- Soh-med-24-0614MS
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Jul 2024 (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.
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.
Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques.
Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI).
, and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .
Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world .
The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ; has emerged as an important inflammatory markers for cardiovascular risk stratification.
And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes
Detailed description
Acute myocardial infarction (AMI) is a serious and fatal cardiovascular emergency and considered the leading cause of mortality worldwide.
- Atherosclerosis of coronary arteries which takes decades to manifest clinically, is the primary predisposing pathologic factor responsible for the development of coronary heart disease
- It has been shown that A complex immune and inflammatory pathophysiological process is thought to be crucial for in the initiation and progression of atherosclerotic plaques
- Inflammation is one of the main mechanisms in the pathogenesis of atherosclerosis , Destabilization of chronic artery plaques and development of thrombosis, which are the main mechanisms in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) . , and the interest to the evaluation of inflammatory biomarkers in coronary artery disease (CAD) has been increasing over the last decade .
- Although numerous inflammatory markers, including troponin T/I, lactate dehydrogenase (LDH), and creatine kinase (CK-MB), are linked to worsened clinical outcomes in both ST elevation and non-ST elevation myocardial infarction (NSTEMI), there is an unmet need for a cost-effective biomarker for impoverished countries of the world
- The neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP) ;
- has emerged as an important inflammatory markers for cardiovascular risk stratification.
- And are relatively cheap inflammatory markers, can act as a bridge to mitigate the gap in assessing the cardiovascular risk and outcomes In patients with acute myocardial infarction.
- Recent data indicates a strong independent relationship between increased complications after acute myocardial infarction in patients with a high NLR and high CRP level at admission and the initial post-hospitalization period.
- Accordingly, we designed this study to assess the predictive value and prognosis of NLR and CRP in ST-elevation myocardial infarction (STEMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevated NLR and CRP level | – | Diagnostic Test: CBC, Diagnostic Test: C-reactive proteinElevated NLR and CRP level |
| Normal NLR and CRP level | – | Diagnostic Test: CBC, Diagnostic Test: C-reactive proteinElevated NLR and CRP level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI
Key inclusion criteria (1 listed)
- Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI.
Key exclusion criteria (9 listed)
- Patients presenting with NSTEMI and unstable angina
- Patients with any of these associated conditions that can affect NLR or CRP including
- Inflammatory conditions such as collagen-vascular disorders
- Acute or chronic infectious diseases.
- Auto-immune and neoplastic diseases.
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 |
|---|---|---|
| CBCExplore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction | Diagnostic test | Elevated NLR and CRP level, Normal NLR and CRP level |
| C-reactive proteinExplore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction | Diagnostic test | Elevated NLR and CRP level, Normal NLR and CRP level |
Primary outcome
Neutrophil-lymphocyte ratio
Time frame: 6 months
Explore the role of Neutrophil-lymphocyte ratio in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
C-reactive protein
Time frame: 6 months
C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Results publication: PubMed 18452792Gualandro DM, Caramelli B, Yu PC, Marques AC, Calderaro D. Perioperative myocardial infarction has been forgotten. J Am Coll Cardiol. 2008 May 6;51(18):1825-6; author reply 1826. doi: 10.1016/j.jacc.2008.01.035. No abstract available.
- Results publication: PubMed 24436429Sahoo S, Losordo DW. Exosomes and cardiac repair after myocardial infarction. Circ Res. 2014 Jan 17;114(2):333-44. doi: 10.1161/CIRCRESAHA.114.300639.
- Results publication: PubMed 20644187Kuklina EV, Yoon PW, Keenan NL. Prevalence of coronary heart disease risk factors and screening for high cholesterol levels among young adults, United States, 1999-2006. Ann Fam Med. 2010 Jul-Aug;8(4):327-33. doi: 10.1370/afm.1137.
- Results publication: PubMed 11877368Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
- 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.
Sharaf El-DEEN Sh Abd-Allah, Professor contact
Magdy M Amin, Professor principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Sohag University at 1 site in Egypt.
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 9 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 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Albair Y Kaiser, Resident (01010095136, Alberyouseef@med.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-lymphocyte ratio (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT06491667, which also lists 4 linked publications.
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 9 Jul 2024.