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临床试验/NCT07369037
NCT07369037已完成不适用

Association of Prognostic Nutritional Index and Controlling Nutritional Status Score With 2-Year Clinical Outcomes in Patients With ST Elevation Myocardial Infarction

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Relationship between CONUT score and PNI index and mortality

研究概览

简要总结

It is well known that malnutrition is a prognostic risk factor in chronic heart failure (CHF). Weight loss and the development of cardiac cachexia are associated with poor prognosis in CHF. However, objective indices such as the Prognostic Nutrition Index (PNI) and Controlling Nutritional Status (CONUT) have been developed and are widely used today to assess nutritional status. The CONUT index is an effective scoring system for monitoring pre- and post-hospital malnutrition status and is measured by serum albumin level, total cholesterol (TC), and lymphocyte count. PNI, calculated from serum albumin level and lymphocyte count, is another formula reflecting nutritional status and is well known to be associated with the risk of perioperative complications, especially in surgical patients. Only simple blood biomarkers are required to determine these two indices. The aim of this study is to evaluate the effect of nutritional status at admission, assessed by two objective nutritional indices, CONUT and PNI, on the outcomes of STEMI (ST elevation myocardial infarction) patients during a median follow-up period of two years.

详细描述

The prognostic impact of nutritional status in cardiovascular disease (CVD) is not fully understood. Clinical studies have shown that low serum albumin levels are associated with an increased risk of heart failure. Similarly, particularly in recent studies, hypoalbuminemia at hospital admission has been shown to independently predict long-term mortality in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Malnutrition is well-known to be a prognostic risk factor in chronic heart failure (CHF). Weight loss and the development of cardiac cachexia are associated with poor prognosis in CHF. However, objective indices such as the Prognostic Nutrition Index (PNI) and Controlling Nutritional Status (CONUT) have been developed and are widely used today to assess nutritional status. The CONUT index is an effective scoring system for monitoring pre- and post-hospital malnutrition status and is measured by serum albumin level, total cholesterol (TC), and lymphocyte count. PNI, calculated using serum albumin level and lymphocyte count, is another formula reflecting nutritional status and is well-known to be associated with the risk of perioperative complications, especially in surgical patients. Only simple blood biomarkers are required to determine these two indices.

The aim of this study is to evaluate the effect of nutritional status at admission, assessed by two objective nutritional indices, CONUT and PNI, on the outcomes of STEMI patients during a median follow-up period of two years.

Variables will be expressed as frequency, mean, and standard deviation, and patients will be categorized according to their CONUT score (low ≤ 2 - high ≥ 3) and PNI score (PNI ≥ 45 and PNI < 45). The Pearson Chi-square test will be used to investigate whether there are differences between subgroups in terms of CONUT and PNI scores. If a normal distribution is observed for continuous variables, a Student t-test will be performed to determine the difference between groups. The method planned was to retrospectively analyze all consecutive patients diagnosed with STEMI who underwent primary percutaneous coronary intervention at three different centers (Muğla Training and Research Hospital Cardiology Clinic, Eskişehir City Hospital Cardiology Clinic, and Eskişehir Osmangazi Faculty of Medicine Cardiology Clinic). Laboratory, ECG, and echocardiographic findings at admission, as well as in-hospital and long-term outcomes, were planned to be monitored from patient files.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients over 18 years of age diagnosed with ST-elevation myocardial infarction (STEMI) treated percutaneously within the specified date range.

排除标准

  • Patients under 18 years of age Patients for whom laboratory data is unavailable Patients with incomplete data Patients diagnosed with cancer Patients with hematological diseases Patients using glucocorticoid drugs Patients with liver disease Patients with kidney disease

结局指标

主要结局

Relationship between CONUT score and PNI index and mortality

时间窗: 2 years

The aim of this study is to evaluate the impact of nutritional status at admission, assessed by two objective nutritional indices, CONUT and PNI, on outcomes in STEMI patients during a median follow-up period of two years.Patients will be categorized according to their CONUT score (low ≤ 2 - high ≥ 3) and PNI score (PNI ≥ 45 and PNI \< 45). The relationship between CONUT and PNI scores and mortality will be investigated.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

OGUZHAN CELIK

Associate Professor

Muğla Sıtkı Koçman University

研究点 (1)

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