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

Myocard Infarctus Clinical Trial

— non-STEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763213
• Other study ID #: 05.08.2020-2020/15/10
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• NonST elevated myocard infarctus

• 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

Related Conditions & MeSH terms

• Myocard Infarctus

Intervention

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)
• Coronary Angiography
Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically

Locations

Country	Name	City	State
Turkey	Ekrem Aksu	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Aktoz M, Altay H, Aslanger E, Atalar E, Aytekin V, Baykan AO, Barçin C, Baris N, Boyaci AA, Çavusoglu Y, Çelik A, Çinier G, Degertekin M, Ergönül Ö, Ertürk M, Erol MK, Görenek B, Gürsoy MO, Hünük B, Kahveci G, Karabay CY, Karaca I, Kayikçioglu M, Keskin M — View Citation

Arbel Y, Finkelstein A, Halkin A, Birati EY, Revivo M, Zuzut M, Shevach A, Berliner S, Herz I, Keren G, Banai S. Neutrophil/lymphocyte ratio is related to the severity of coronary artery disease and clinical outcome in patients undergoing angiography. Ath — View Citation

Azab B, Zaher M, Weiserbs KF, Torbey E, Lacossiere K, Gaddam S, Gobunsuy R, Jadonath S, Baldari D, McCord D, Lafferty J. Usefulness of neutrophil to lymphocyte ratio in predicting short- and long-term mortality after non-ST-elevation myocardial infarction — View Citation

Collet JP, Thiele H. The 'Ten Commandments' for the 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2020 Oct 1;41(37):3495-3497. doi: 10.1093/eurheartj/ehaa624 — View Citation

Isik T, Uyarel H, Tanboga IH, Kurt M, Ekinci M, Kaya A, Ayhan E, Ergelen M, Bayram E, Gibson CM. Relation of red cell distribution width with the presence, severity, and complexity of coronary artery disease. Coron Artery Dis. 2012 Jan;23(1):51-6. doi: 10 — View Citation

Sabatine MS, Morrow DA, Cannon CP, Murphy SA, Demopoulos LA, DiBattiste PM, McCabe CH, Braunwald E, Gibson CM. Relationship between baseline white blood cell count and degree of coronary artery disease and mortality in patients with acute coronary syndrom — View Citation

Sansanayudh N, Anothaisintawee T, Muntham D, McEvoy M, Attia J, Thakkinstian A. Mean platelet volume and coronary artery disease: a systematic review and meta-analysis. Int J Cardiol. 2014 Aug 20;175(3):433-40. doi: 10.1016/j.ijcard.2014.06.028. Epub 2014 — View Citation

Temiz A, Gazi E, Güngör Ö, Barutçu A, Altun B, Bekler A, Binnetoglu E, Sen H, Günes F, Gazi S. Platelet/lymphocyte ratio and risk of in-hospital mortality in patients with ST-elevated myocardial infarction. Med Sci Monit. 2014 Apr 22;20:660-5. doi: 10.126 — View Citation

Yang YL, Wu CH, Hsu PF, Chen SC, Huang SS, Chan WL, Lin SJ, Chou CY, Chen JW, Pan JP, Charng MJ, Chen YH, Wu TC, Lu TM, Huang PH, Cheng HM, Huang CC, Sung SH, Lin YJ, Leu HB. Systemic immune-inflammation index (SII) predicted clinical outcome in patients — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive factors for Non ST elevated MI Blood prarameters Predictive factors for Non ST eleveted MI	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