Predictive Value of NT-proBNP on MACEs After Acute Coronary Syndrome (MACEstdy)

August 22, 2024 updated by: Adem Az, Haseki Training and Research Hospital

Predictive Value of NT-proBNP on Major Adverse Cardiovascular Events in Patients With Acute Coronary Syndrome During a 6-month Follow-up

The role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) as a cardiac biomarker in predicting short-term major adverse cardiovascular events (MACEs) in patients with Acute coronary syndrome (ACS) has been insufficiently reported and remains poorly understood. Additionally, the relationship between NT-proBNP levels and specific ACS subtypes has not been thoroughly examined. Therefore, our study investigated the predictive value of high-sensitivity cardiac troponin (hs-cTn) and NT-proBNP levels on admission for 6-month MACEs in patients who presented to the emergency department (ED) with ACS and subsequently underwent percutaneous coronary intervention (PCI). Furthermore, we sought to evaluate the association between MACEs and specific ACS subtypes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In patients diagnosed with Acute coronary syndrome (ACS) based on anamnesis, clinical findings, electrocardiogram (ECG), and/or serum high-sensitivity cardiac troponin (hs-cTn) level in the emergency department (ED), blood samples for serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) value was additionally taken during transfer to the coronary intensive care unit, and left ventricular ejection fraction (LVEF) was calculated by echocardiography before percutaneous coronary intervention (PCI). In addition, demographics (age, sex, and smoking status), comorbidities (hypertension, diabetes mellitus [DM] and/or coronary artery disease [CAD]), initial complaints and diagnoses, vital signs (systolic blood pressure [SBP], heart rate [HR], and peripheral capillary oxygen saturation [SpO2]), laboratory parameters (serum creatinine, C-reactive protein, and hs-cTn), and ACS subtypes (ST-elevation Myocardial infarction [STEMI], non-ST-elevation Myocardial infarction [NSTEMI], or unstable angina pectoris [USAP]) were obtained during admission. GRACE risk score was calculated for each patient on admission using eight variables, including age, SBP, HR, and serum creatinine. At the end of the 6-month follow-up period, LVEF of surviving patients was assessed by control echocardiography. The short-term MACEs (e.g., nonfatal ischemic stroke, nonfatal myocardial infarction, cardiovascular mortality, or ED admission due to heart failure) were recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34265
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This prospective, observational, and single-center study included a total of 241 consecutive adult patients (≥18 years old) who were admitted to the emergency department with Acute coronary syndrome, including ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, or Unstable Angina Pectoris between September 2023 and February 2024.

Description

Inclusion Criteria:

  • Adult patients (≥18 years old) who were admitted to the emergency department with Acute coronary syndrome and underwent percutaneous coronary intervention between September 2023 and February 2024.

Exclusion Criteria:

  • patients younger than 18 years
  • patients had no vascular lesions detected on percutaneous coronary intervention,
  • patients had infective or structural cardiac pathologies (myocarditis, pericarditis, hypertrophic or dilated cardiomyopathies)
  • patients had chronic heart failure with LVEF <40%, class 3 and 4 in the Killip classification
  • patients had a diagnosis of malignancy, chronic renal failure, chronic liver failure, and a history of multiple trauma or surgery within the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
MACE-positive
Patients who have experienced a major adverse cardiovascular event (MACE) within a 6-month period after percutaneous coronary intervention (PCI), including nonfatal ischemic stroke, nonfatal myocardial infarction, cardiovascular mortality, or emergency department admission due to heart failure.
Diagnostic test: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
In patients diagnosed with Acute coronary syndrome, blood samples for serum NT-proBNP value were taken during transfer to the coronary intensive care unit
Diagnostic test: high sensitive cardiac troponin T (hs-cTnT)
In patients diagnosed with Acute coronary syndrome, serum high-sensitive cardiac troponin T (hs-cTnT) levels were measured on admission to the Emergency Department.
MACE-negative
Patients who have not experienced a major adverse cardiovascular event (MACE) within a 6-month period after percutaneous coronary intervention (PCI), including nonfatal ischemic stroke, nonfatal myocardial infarction, cardiovascular mortality, or emergency department admission due to heart failure.
Diagnostic test: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
In patients diagnosed with Acute coronary syndrome, blood samples for serum NT-proBNP value were taken during transfer to the coronary intensive care unit
Diagnostic test: high sensitive cardiac troponin T (hs-cTnT)
In patients diagnosed with Acute coronary syndrome, serum high-sensitive cardiac troponin T (hs-cTnT) levels were measured on admission to the Emergency Department.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive ability of NT-proBNP for 6-months MACEs
Time Frame: From admission to 6 months
The investigators assessed the effectiveness of N-terminal pro-B-type natriuretic peptide (NT-proBNP) value at admission in predicting 6-months major adverse cardiovascular events (MACEs) in patients with acute coronary syndrome.
From admission to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of MACEs in STEMI
Time Frame: From admission to 6 months
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with ST-elevation myocardial infarction (STEMI).
From admission to 6 months
Incidence of MACEs in NSTEMI
Time Frame: From admission to 6 months
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with non-ST-elevation myocardial infarction (NSTEMI).
From admission to 6 months
Incidence of MACEs in USAP
Time Frame: From admission to 6 months
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with unstable angina pectoris (USAP).
From admission to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haseki Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adem Az, M.D., Haseki Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 164-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Stored in non-publicly available Available on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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