Clinical Trials Directory

Trials / Completed

CompletedNCT07369037

Association of Prognostic Nutritional Index and Controlling Nutritional Status Score With ST Elevation Myocardial Infarction

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,000 (actual)
Sponsor
Muğla Sıtkı Koçman University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2022-01-01
Primary completion
2024-12-31
Completion
2025-03-01
First posted
2026-01-27
Last updated
2026-01-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07369037. Inclusion in this directory is not an endorsement.