New Predictors in Determining the Need for Invasive Treatment in Non-STEMI (non-STEMI)

February 18, 2021 updated by: Ekrem Aksu, Kahramanmaras Sutcu Imam University

New Predictors in Determining the Need for Invasive Treatment in Non-STEMI During the COVID-19 Pandemic: A Retrospective Study

Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.

Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-ST elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous disease with a wide range of treatment options from the medical follow-up to early invasive treatment due to complete occlusion of the culprit artery. Non-ST elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) is one of the subcomponents of NSTE-ACS, which has an increased mortality rate, and for which early intervention can be vital. In the European Society of Cardiology (ESC) guidelines, NSTEMI-ACS is defined as a high-risk condition that requires diagnostic angiography within 2 hours at the latest in those with very high-risk criteria and within 24 hours at the latest in those who do not have high risk. However, the non-invasive approach has come to the fore for the NSTEMI-ACS disease due to the COVID-19 pandemic conditions. In the recently published national consensus report, during the COVID-19 pandemic period, medium-high risk NSTEMI-ACS patients are recommended optimal medical therapy as an alternative treatment method, even if the diagnosis of COVID-19 was excluded, especially in areas where pandemic effects are being experienced intensely. Yet, most of these patients require invasive treatment. In fact, some of them are patients who require very early invasive treatment and have a complete occlusion in the culprit artery. Unfortunately, risk scoring systems are not sufficient enough to differentiate these patients. Therefore, the discovery of markers that can be used in the differentiation of NSTEMI-ACS patients with an increased need for invasive treatment and/or complete occlusion of the culprit's vessels, especially during pandemic periods such as the COVID-19 pandemic, has gained importance.

Inflammation is known to play an important role in the etiopathogenesis of coronary artery disease. In recent years, it has been shown that hematological parameters closely associated with inflammation in people with coronary artery disease may be useful in distinguishing those with increased severity of atherosclerotic involvement and those with high mortality risk. The main markers used in studies are Leukocyte count, neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte Ratio (PLR), systemic immune inflammation index (SII), red blood cell distribution width (RDW), and mean platelet volume (MPV). To the best of our knowledge, there is a lack of literature on the relationship between the need for invasive treatment strategy and/or complete occlusion of the culprit's vessel, and the hematological markers in patients diagnosed with NSTEMI-ACS.

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46050
        • Ekrem Aksu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Between January 2018 and December 2019, patients admitted to the Cardiology clinic of a tertiary care hospital with a diagnosis of NSTEMI-ACS were evaluated consecutively

Description

Inclusion Criteria:

  • NonST elevated myocard ınfarctus
  • Elder than 18 years
  • Patients who were not have the exclusion criterias

Exclusion Criteria:

  • Under the age of 18,
  • Recurrent or ongoing chest pain resistant to drug therapy,
  • Hemodynamic instability,
  • Life-threatening ventricular arrhythmias or cardiac arrest,
  • Development of mechanical complications and the presence of dynamic ST-T wave changes (intermittent ST-segment elevation),
  • Heart failure,
  • Ejection fraction <40,
  • Severe anemia,
  • Sepsis,
  • Malignancy,
  • Chronic hematological disease,
  • Collagen tissue disease
  • Obesity,
  • Moderate to severe hepatic failure,
  • Renal failure (Glomerular filtration rate <60 ml/min/1.73 m2),
  • Severe valvular heart disease,
  • Electrolyte disturbance,
  • Chronic anti-inflammatory drug use,
  • History of chronic inflammatory disease,
  • A history of serious infection in the last month
  • Patients with missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Invasive treatment
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)
Diagnostic test: Coronary Angiography
Patients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)
Other Names:
  • Invasive treatment
Diagnostic test: Coronary Angiography
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically
Other Names:
  • Medical treatment
Medically treatment
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically
Diagnostic test: Coronary Angiography
Patients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)
Other Names:
  • Invasive treatment
Diagnostic test: Coronary Angiography
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically
Other Names:
  • Medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI
Time Frame: Pretreatment period
The relationship between inflammation markers such as red cell distribution width (%), mean platelet volume (fL), Systemic immune-inflammation index (platelet count (10^9/L)x neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), neutrophil to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), platelet to lymphocyte ratio (neutrophil count (10^9/L)/ lymphocyte count (10^9/L)), and treatment strategy in patients diagnosed with Non-ST myocardial infarction was investigated.
Pretreatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (ACTUAL)

February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05.08.2020-2020/15/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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