- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369037
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
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Muğla
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Menteşe, Muğla, Turkey (Türkiye), 48050
- Mugla Sitki Kocman University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients over 18 years of age diagnosed with ST-elevation myocardial infarction (STEMI) treated percutaneously within the specified date range.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship between CONUT score and PNI index and mortality
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- muglaSKU-CRD-OC-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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