NCT06491667

Brief 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 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

Trial Health

57
Monitor

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 all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 1, 2024

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Neutrophil-lymphocyte ratio

    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

    C-reactive protein in predicting the imediate and short-term prognosis in ST-segment elevation myocardial infarction

    6 months

Study Arms (2)

Elevated NLR and CRP level

Elevated NLR and CRP level

Diagnostic Test: CBCDiagnostic Test: C-reactive protein

Normal NLR and CRP level

Elevated NLR and CRP level

Diagnostic Test: CBCDiagnostic Test: C-reactive protein

Interventions

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

Elevated NLR and CRP levelNormal NLR and CRP level
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

Elevated NLR and CRP levelNormal NLR and CRP level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI

You may qualify if:

  • Patients with age ≥18 years of either sex, with either increase in serum cardiac biomarkers or ECG are STEMI.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Magdy M Amin, Professor

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albair Y Kaiser, Resident

CONTACT

Sharaf El-DEEN Sh Abd-Allah, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Internal Medicine Department Sohag University hospital

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations