Clinical trial NCT04763213: New Predictors in Determining the Need for Invasive Treatment in Non-STEMI
Official title: New Predictors in Determining the Need for Invasive Treatment in Non-STEMI During the COVID-19 Pandemic: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocard Infarctus
Keywords: Non-ST elevation myocardial infarction acute coronary syndrome
Neutrophil-lymphocyte ratio
Systemic immune inflammation index
Invasive treatment strategy
Conservative strategy
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI
timeFrame: Pretreatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Ekrem Aksu
Study officials:
References:
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