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

NCT04763213 | Completed

• 1 other identifier: 05.08.2020-2020/15/10
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocard Infarctus

Keywords

Non-ST elevation myocardial infarction acute coronary syndrome; Neutrophil-lymphocyte ratio; Systemic immune inflammation index; Invasive treatment strategy; Conservative strategy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Medically treatment

Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically

Diagnostic Test: Coronary Angiography

Interventions

Coronary Angiography DIAGNOSTIC_TEST

Patients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)

Also known as: Invasive treatment

Invasive treatment; Medically treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• NonST elevated myocard ınfarctus
• Elder than 18 years

You may not qualify if:

• 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),

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Ekrem Aksu

Kahramanmaraş, 46050, Turkey (Türkiye)

Location

Related Publications (9)

• 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. No abstract available.

  PMID: 33085966 RESULT

• Aktoz M, Altay H, Aslanger E, Atalar E, Aytekin V, Baykan AO, Barcin C, Baris N, Boyaci AA, Cavusoglu Y, Celik A, Cinier G, Degertekin M, Ergonul O, Erturk M, Erol MK, Gorenek B, Gursoy MO, Hunuk B, Kahveci G, Karabay CY, Karaca I, Kayikcioglu M, Keskin M, Kilic T, Kirma C, Kocabas U, Kucukoglu S, Mutlu B, Nalbantgil S, Okuyan E, Okyay K, Kaptan Ozen D, Ozgul S, Ozpelit E, Pirat B, Sert S, Sinan UY, Sener YZ, Tatli E, Tekkesin AI, Tutar E, Ural D, Yildirimturk O. [Consensus Report from Turkish Society of Cardiology: COVID-19 and Cardiovascular Diseases. What cardiologists should know. (25th March 2020)]. Turk Kardiyol Dern Ars. 2020 Mar;48(Suppl 1):1-48. doi: 10.5543/tkda.2020.97198. Turkish.

  PMID: 32250347 RESULT

• 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 syndromes: a TACTICS-TIMI 18 (Treat Angina with Aggrastat and determine Cost of Therapy with an Invasive or Conservative Strategy- Thrombolysis in Myocardial Infarction 18 trial)substudy. J Am Coll Cardiol. 2002 Nov 20;40(10):1761-8. doi: 10.1016/s0735-1097(02)02484-1.

  PMID: 12446059 RESULT

• 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. Am J Cardiol. 2010 Aug 15;106(4):470-6. doi: 10.1016/j.amjcard.2010.03.062.

  PMID: 20691303 RESULT

• 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. Atherosclerosis. 2012 Dec;225(2):456-60. doi: 10.1016/j.atherosclerosis.2012.09.009. Epub 2012 Sep 21.

  PMID: 23040448 RESULT

• Temiz A, Gazi E, Gungor O, Barutcu A, Altun B, Bekler A, Binnetoglu E, Sen H, Gunes 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: 10.12659/MSM.890152.

  PMID: 24751474 RESULT

• 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 Jun 28.

  PMID: 25017904 RESULT

• 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: 10.1097/MCA.0b013e32834e4f5c.

  PMID: 22133925 RESULT

• 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 with coronary artery disease. Eur J Clin Invest. 2020 May;50(5):e13230. doi: 10.1111/eci.13230. Epub 2020 May 11.

  PMID: 32291748 RESULT

MeSH Terms

Interventions

Coronary Angiography; Medical Futility

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Prognosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assis. Prof., MD (Cardiology)

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)