Clinical trial NCT06569511: Predictive Value of NT-proBNP on MACEs After Acute Coronary Syndrome
Official title: Predictive Value of NT-proBNP on Major Adverse Cardiovascular Events in Patients With Acute Coronary Syndrome During a 6-month Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive ability of NT-proBNP for 6-months MACEs
timeFrame: From admission to 6 months
Secondary outcomes:
measure: Incidence of MACEs in STEMI
timeFrame: From admission to 6 months
measure: Incidence of MACEs in NSTEMI
timeFrame: From admission to 6 months
measure: Incidence of MACEs in USAP
timeFrame: From admission to 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Fatih
Study officials:
affiliation: Haseki Training and Research Hospital
name: Adem Az, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.