CONUT ScoreNCT07369037
Association of Prognostic Nutritional Index and Controlling Nutritional Status Score With ST Elevation Myocardial Infarction
An observational study of CONUT Score and ST Elevation (STEMI) Myocardial Infarction, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CONUT Score, ST Elevation (STEMI) Myocardial Infarction, Mortality
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Mar 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective analysis of all major sequential calculations in 18 stages of past ST-elevation myocardial infarction (STEMI) diagnoses was planned. The analysis would examine disease-triggering factors, laboratory findings at admission, ECG and echocardiographic findings, as well as distribution, in-hospital, and long-term outcomes.
Who may be able to join
- All patients over 18 years of age diagnosed with ST-elevation myocardial infarction (STEMI) treated percutaneously within the specified date range.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University
Menteşe, Muğla, 48050
About this study
Official title: Association of Prognostic Nutritional Index and Controlling Nutritional Status Score With 2-Year Clinical Outcomes in Patients With ST Elevation Myocardial Infarction
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.
Read the 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.
- Keywords
- conut score, pni score, ST Elevation (STEMI) Myocardial Infarction, mortality, quality of life
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between CONUT score and PNI index and mortality
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CONUT ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OGUZHAN CELIK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369037
- Sponsor's protocol ID
- muglaSKU-CRD-OC-03
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Prognostic Nutritional Index and Controlling Nutritional Status Score With 2-Year Clinical Outcomes in Patients With ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07369037
- Acronym / sponsor ID
- muglaSKU-CRD-OC-03
- Keywords
- conut score, pni score, ST Elevation (STEMI) Myocardial Infarction, mortality, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective analysis of all major sequential calculations in 18 stages of past ST-elevation myocardial infarction (STEMI) diagnoses was planned. The analysis would examine disease-triggering factors, laboratory findings at admission, ECG and echocardiographic findings, as well as distribution, in-hospital, and long-term outcomes.
Key inclusion criteria (1 listed)
- All patients over 18 years of age diagnosed with ST-elevation myocardial infarction (STEMI) treated percutaneously within the specified date range.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CONUT Score and ST Elevation (STEMI) Myocardial Infarction, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between CONUT score and PNI index and mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.