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

NCT ID: NCT04763213

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Myocard Infarctus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Invasive treatment

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

Coronary Angiography

Intervention Type DIAGNOSTIC_TEST

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

Coronary Angiography

Intervention Type DIAGNOSTIC_TEST

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

Medically treatment

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

Coronary Angiography

Intervention Type DIAGNOSTIC_TEST

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

Coronary Angiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Coronary Angiography

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

Intervention Type DIAGNOSTIC_TEST

Coronary Angiography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Invasive treatment Medical treatment

Eligibility Criteria

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Inclusion Criteria

* NonST elevated myocard ınfarctus
* Elder than 18 years

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Ekrem Aksu

Clinical Assis. Prof., MD (Cardiology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ekrem Aksu

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33085966 (View on PubMed)

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.

Reference Type RESULT
PMID: 32250347 (View on PubMed)

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.

Reference Type RESULT
PMID: 12446059 (View on PubMed)

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.

Reference Type RESULT
PMID: 20691303 (View on PubMed)

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.

Reference Type RESULT
PMID: 23040448 (View on PubMed)

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.

Reference Type RESULT
PMID: 24751474 (View on PubMed)

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.

Reference Type RESULT
PMID: 25017904 (View on PubMed)

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.

Reference Type RESULT
PMID: 22133925 (View on PubMed)

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.

Reference Type RESULT
PMID: 32291748 (View on PubMed)

Other Identifiers

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05.08.2020-2020/15/10

Identifier Type: -

Identifier Source: org_study_id

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