- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491667
NLR AND CRP Useful as Cost-Effective Preliminary Prognostic Markers in ST-Elevation Myocardial Infarction
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.
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Albair Y Kaiser, Resident
- Phone Number: 01010095136
- Email: Alberyouseef@med.edu.eg
Study Contact Backup
- Name: Sharaf El-DEEN Sh Abd-Allah, Professor
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI.
Exclusion Criteria:
- 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.
- Renal failure.
- Thyroid disorders.
- Previous valvular heart disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elevated NLR and CRP level
|
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
|
|
Normal NLR and CRP level
Elevated NLR and CRP level
|
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
Explore the role of Neutrophil-lymphocyte ratio C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
|
C-reactive protein
Time Frame: 6 months
|
C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Magdy M Amin, Professor, Sohag University
Publications and helpful links
General 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.
- Sahoo 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.
- Kuklina 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.
- Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-med-24-0614MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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