Acute Coronary SyndromesNCT06734416
Evaluation of the Role of Brain Natriuretic Peptide in Acute Coronary Syndrome .
An observational study of Acute Coronary Syndromes, run by Assiut University.
Trial summary
The measurements of the natriuretic peptide are useful and beneficial for risk stratification irrespective of the cause during admission time or during hospital stay course. the aim of the study is to Assessment of the role of Brain natriuretic peptide in diagnosis of acute coronary syndrome . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with acute coronary syndrome.
Who may be able to join
- patients with acute coronary syndrome.
Who cannot join
- Patients with previous MI
- Eection fraction (EF) less than 30%
- Patients having cardiomyopathy
- Patients having renal, liver, malignant, infectious, or inflammatory diseases .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The measurements of the natriuretic peptide are useful and beneficial for risk stratification irrespective of the cause during admission time or during hospital stay course. the aim of the study is to Assessment of the role of Brain natriuretic peptide in diagnosis of acute coronary syndrome . Evaluation of the relation of Brain natriuretic peptide to the severity and occurrence of complications in acute coronary syndrome .
Read the detailed description
Ischemic heart disease (IHD) is regarded as one of the important leading causes of disability and death across the globe.
Acute coronary syndrome (ACS) applies to a variety of events reporting ischemia, ranging from stable angina without myocardial necrosis to ST -segment elevation myocardial infarction (STEMI). The need for prevention and detection of coronary vascular disease as early as possible by using newer and more cost effective tools is suggested . For risk stratification in patients with ACS, serial ECG monitoring and cardiac biomarkers measurement are needed as part of the diagnostic workup. B-type natriuretic peptide is synthesized as a high molecular weight precursor pro-brain natriuretic peptide (BNP) which is cleaved to release BNP and the amino-terminal fragment, N-terminal pro (NT-pro) BNP. Both peptides are released from the cardiac ventricles in response to the increased wall stress and hence its levels may indicate ventricular strain BNP is believed to have its role as natriuretic hormone and vasodilation. Among other effects are inhibition of the Renin Angiotensin-Aldosterone system(RAAS), and sympathetic nervous system. After an ischemic occurrence, BNP levels peak in 14 to 40 hours .
- Conditions
- Acute Coronary Syndromes
- Keywords
- Brain natriuretic peptide
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patients with Acute Coronary Syndrome , this group will be sub classified into: Non-ST-elevation myocardial infarction (NSTEMI) ST-elevation myocardial infarction (STEMI) Unstable angina | |
| group 2 | apparently healthy patients will be included in this study as a control group for comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain natriuretic peptide level in blood
level of Brain natriuretic peptide in acute coronary syndrome patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat-Allah Gamal kamel Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734416
- Sponsor's protocol ID
- BNP IN ACS
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Volterrani M, Iellamo F, Senni M, Piepoli MF. Therapeutic options of Angiotensin Receptor Neprilysin inhibitors (ARNis) in chronic heart failure with reduced ejection fraction: Beyond RAAS and sympathetic nervous system inhibition. Int J Cardiol. 2017 Jan 1;226:132-135. doi: 10.1016/j.ijcard.2016.04.180. Epub 2016 May 7.
PubMed 27184730Mukoyama M, Nakao K, Hosoda K, Suga S, Saito Y, Ogawa Y, Shirakami G, Jougasaki M, Obata K, Yasue H, et al. Brain natriuretic peptide as a novel cardiac hormone in humans. Evidence for an exquisite dual natriuretic peptide system, atrial natriuretic peptide and brain natriuretic peptide. J Clin Invest. 1991 Apr;87(4):1402-12. doi: 10.1172/JCI115146.
PubMed 1849149
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Brain Natriuretic Peptide in Acute Coronary Syndrome .
- ClinicalTrials.gov ID
- NCT06734416
- Acronym / sponsor ID
- BNP IN ACS
- Conditions
- Acute Coronary Syndromes
- Keywords
- Brain natriuretic peptide
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Dec 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 measurements of the natriuretic peptide are useful and beneficial for risk stratification irrespective of the cause during admission time or during hospital stay course. the aim of the study is to Assessment of the role of Brain natriuretic peptide in diagnosis of acute coronary syndrome . Evaluation of the relation of Brain natriuretic peptide to the severity and occurrence of complications in acute coronary syndrome .
Detailed description
Ischemic heart disease (IHD) is regarded as one of the important leading causes of disability and death across the globe.
Acute coronary syndrome (ACS) applies to a variety of events reporting ischemia, ranging from stable angina without myocardial necrosis to ST -segment elevation myocardial infarction (STEMI). The need for prevention and detection of coronary vascular disease as early as possible by using newer and more cost effective tools is suggested . For risk stratification in patients with ACS, serial ECG monitoring and cardiac biomarkers measurement are needed as part of the diagnostic workup. B-type natriuretic peptide is synthesized as a high molecular weight precursor pro-brain natriuretic peptide (BNP) which is cleaved to release BNP and the amino-terminal fragment, N-terminal pro (NT-pro) BNP. Both peptides are released from the cardiac ventricles in response to the increased wall stress and hence its levels may indicate ventricular strain BNP is believed to have its role as natriuretic hormone and vasodilation. Among other effects are inhibition of the Renin Angiotensin-Aldosterone system(RAAS), and sympathetic nervous system. After an ischemic occurrence, BNP levels peak in 14 to 40 hours .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –patients with Acute Coronary Syndrome , this group will be sub classified into: Non-ST-elevation myocardial infarction (NSTEMI) ST-elevation myocardial infarction (STEMI) Unstable angina |
| group 2 | – | –apparently healthy patients will be included in this study as a control group for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute coronary syndrome.
Key inclusion criteria (1 listed)
- patients with acute coronary syndrome.
Key exclusion criteria (4 listed)
- Patients with previous MI
- Eection fraction (EF) less than 30%
- Patients having cardiomyopathy
- Patients having renal, liver, malignant, infectious, or inflammatory diseases .
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
Brain natriuretic peptide level in blood
Time frame: baseline
level of Brain natriuretic peptide in acute coronary syndrome patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 27184730Volterrani M, Iellamo F, Senni M, Piepoli MF. Therapeutic options of Angiotensin Receptor Neprilysin inhibitors (ARNis) in chronic heart failure with reduced ejection fraction: Beyond RAAS and sympathetic nervous system inhibition. Int J Cardiol. 2017 Jan 1;226:132-135. doi: 10.1016/j.ijcard.2016.04.180. Epub 2016 May 7.
- Results publication: PubMed 1849149Mukoyama M, Nakao K, Hosoda K, Suga S, Saito Y, Ogawa Y, Shirakami G, Jougasaki M, Obata K, Yasue H, et al. Brain natriuretic peptide as a novel cardiac hormone in humans. Evidence for an exquisite dual natriuretic peptide system, atrial natriuretic peptide and brain natriuretic peptide. J Clin Invest. 1991 Apr;87(4):1402-12. doi: 10.1172/JCI115146.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennat-Allah Gamal kamel Mohamed, resident doctor (+201098695613, mennagamalkamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain natriuretic peptide level in blood (time frame: baseline). 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 NCT06734416, which also lists 2 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 16 Dec 2024.