Acute Coronary SyndromeMACEstdyNCT06569511
Predictive Value of NT-proBNP on MACEs After Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and ST-segment Elevation Myocardial Infarction (STEMI), run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, ST-segment Elevation Myocardial Infarction (STEMI), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
- What is being tested?
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high sensitive cardiac troponin T (hs-cTnT)
- How many people
- 241 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2024
- 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
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Fatih, 34265
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, ST-segment Elevation Myocardial Infarction (STEMI), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Major Adverse Cardiac Events
- Being tested
- N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitive cardiac troponin T (hs-cTnT)
- Keywords
- NT-proBNP, MACEs, Acute coronary syndrome, STEMI, NSTEMI
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: N-terminal pro-B-type natriuretic peptide (NT-proBNP); Diagnostic Test: high sensitive cardiac troponin T (hs-cTnT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to 6 months
Secondary outcomes (3)
Incidence of MACEs in STEMI
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with ST-elevation myocardial infarction (STEMI).
Measured: From admission to 6 months
Incidence of MACEs in NSTEMI
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with non-ST-elevation myocardial infarction (NSTEMI).
Measured: From admission to 6 months
Incidence of MACEs in USAP
The investigators assessed the incidence of major adverse cardiovascular events (MACEs) in patients with unstable angina pectoris (USAP).
Measured: From admission to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
- Investigators
- Adem Az, M.D., Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569511
- Sponsor's protocol ID
- 164-2023
- Acronym
- MACEstdy
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Stored in non-publicly available Available on request
Publications
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.
PubMed 33605111Velilla 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.
PubMed 30249382Castro 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.
PubMed 30916200Vogiatzis 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.
PubMed 27703287Qin 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.
PubMed 34765262
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of NT-proBNP on Major Adverse Cardiovascular Events in Patients With Acute Coronary Syndrome During a 6-month Follow-up
- ClinicalTrials.gov ID
- NCT06569511
- Acronym / sponsor ID
- MACEstdy / 164-2023
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE-positive | – | Diagnostic Test: N-terminal pro-B-type natriuretic peptide (NT-proBNP), Diagnostic Test: high sensitive cardiac troponin T (hs-cTnT)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. |
| MACE-negative | – | Diagnostic Test: N-terminal pro-B-type natriuretic peptide (NT-proBNP), Diagnostic Test: high sensitive cardiac troponin T (hs-cTnT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | MACE-negative, MACE-positive |
| 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. | Diagnostic test | MACE-negative, MACE-positive |
Primary outcome
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.
3 secondary outcomes
Incidence of MACEs in STEMI
Time frame: From admission to 6 months
Incidence of MACEs in NSTEMI
Time frame: From admission to 6 months
Incidence of MACEs in USAP
Time frame: From admission to 6 months
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 26 Aug 2024.
- Results publication: PubMed 33605111Ralapanawa 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.
- Results publication: PubMed 30249382Velilla 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.
- Results publication: PubMed 30916200Castro 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.
- Results publication: PubMed 27703287Vogiatzis 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.
- Results publication: PubMed 34765262Qin 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.
- Individual participant dataSharing planned: No. Stored in non-publicly available Available on request
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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.
Adem Az, M.D. principal investigator
Haseki Training and Research Hospital
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 Acute Coronary Syndrome and ST-segment Elevation Myocardial Infarction (STEMI), run by Haseki Training and Research Hospital 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 5 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 26 Aug 2024. 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?
Predictive ability of NT-proBNP for 6-months MACEs (time frame: From admission to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569511, which also lists 5 linked publications.
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 26 Aug 2024.