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

NCT06569511 | Completed DMC

• 1 other identifier: 164-2023
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Major Adverse Cardiac Events

Keywords

NT-proBNP; MACEs; Acute coronary syndrome; STEMI; NSTEMI

Outcome Measures

Primary Outcomes (1)

• Predictive ability of NT-proBNP for 6-months MACEs

  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 Outcomes (3)

• Incidence of MACEs in STEMI

  From admission to 6 months

• Incidence of MACEs in NSTEMI

  From admission to 6 months

• Incidence of MACEs in USAP

  From admission to 6 months

Study Arms (2)

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); Diagnostic Test: high sensitive cardiac troponin T (hs-cTnT)

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); Diagnostic Test: high sensitive cardiac troponin T (hs-cTnT)

Interventions

N-terminal pro-B-type natriuretic peptide (NT-proBNP) DIAGNOSTIC_TEST

In patients diagnosed with Acute coronary syndrome, blood samples for serum NT-proBNP value were taken during transfer to the coronary intensive care unit

MACE-negative; MACE-positive

high sensitive cardiac troponin T (hs-cTnT) DIAGNOSTIC_TEST

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; MACE-positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (5)

• Ralapanawa U, Sivakanesan R. Epidemiology and the Magnitude of Coronary Artery Disease and Acute Coronary Syndrome: A Narrative Review. J Epidemiol Glob Health. 2021 Jun;11(2):169-177. doi: 10.2991/jegh.k.201217.001. Epub 2021 Jan 7.

  PMID: 33605111 RESULT

• Velilla Moliner J, Gros Baneres B, Povar Marco J, Santalo Bel M, Ordonez Llanos J, Martin Martin A, Temboury Ruiz F. Diagnostic performance of high sensitive troponin in non-ST elevation acute coronary syndrome. Med Intensiva (Engl Ed). 2020 Mar;44(2):88-95. doi: 10.1016/j.medin.2018.07.014. Epub 2018 Sep 21. English, Spanish.

  PMID: 30249382 RESULT

• Castro LT, Santos IS, Goulart AC, Pereira ADC, Staniak HL, Bittencourt MS, Lotufo PA, Bensenor IM. Elevated High-Sensitivity Troponin I in the Stabilized Phase after an Acute Coronary Syndrome Predicts All-Cause and Cardiovascular Mortality in a Highly Admixed Population: A 7-Year Cohort. Arq Bras Cardiol. 2019 Mar;112(3):230-237. doi: 10.5935/abc.20180268. Epub 2019 Jan 7.

  PMID: 30916200 RESULT

• Vogiatzis I, Dapcevic I, Datsios A, Koutsambasopoulos K, Gontopoulos A, Grigoriadis S. A Comparison of Prognostic Value of the Levels of ProBNP and Troponin T in Patients with Acute Coronary Syndrome (ACS). Med Arch. 2016 Jul 27;70(4):269-273. doi: 10.5455/medarh.2016.70.269-273.

  PMID: 27703287 RESULT

• Qin Z, Du Y, Zhou Q, Lu X, Luo L, Zhang Z, Guo N, Ge L. NT-proBNP and Major Adverse Cardiovascular Events in Patients with ST-Segment Elevation Myocardial Infarction Who Received Primary Percutaneous Coronary Intervention: A Prospective Cohort Study. Cardiol Res Pract. 2021 Nov 2;2021:9943668. doi: 10.1155/2021/9943668. eCollection 2021.

  PMID: 34765262 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

In patients diagnosed with Acute Coronary Syndrome based on anamnesis, clinical findings, electrocardiogram (ECG), and/or serum high-sensitivity cardiac troponin (hs-cTn) level in the Emergency Department, 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.

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Adem Az, M.D.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)