Acute Coronary SyndromeNCT06727084
Serum Albumin in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
Our study aims to investigate the predictive value of serum albumin and short-term mortality in patients with Acute Coronary Syndrome (ACS) 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 Syndrome
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 May 2026
- How long will I take part?
- 1 Month
- 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 aged 18 years or older who were admitted to the emergency department or coronary care unit with a diagnosis of acute coronary syndrome (ACS) will be eligible for inclusion.
Who may be able to join
- Patients aged 18 years or older who were admitted to the emergency department or coronary care unit with a diagnosis of acute coronary syndrome (ACS) will be eligible for inclusion.
Who cannot join
- Patients with a history of chronic liver disease, nephrotic syndrome, or other conditions known to affect serum albumin levels.
- Patients receiving albumin infusions or other treatments that could potentially interfere with serum albumin levels.
- Patients with incomplete medical records or missing laboratory data.
- Patients who declined to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine Sohag university
Sohag
Magdy A Zaky, Resident, 2011 29226770, magdyadel@med.sohag.edu.eg
About this study
Official title: Predictive Value of Serum Albumin in Patients With Acute Coronary Syndrome
Our study aims to investigate the predictive value of serum albumin and short-term mortality in patients with Acute Coronary Syndrome (ACS)
Read the detailed description
Acute coronary syndrome (ACS) refers to a group of conditions that include ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina. It is a type of coronary heart disease (CHD), which is responsible for one-third of total deaths in people older than 35. Some forms of CHD can be asymptomatic, but ACS is always symptomatic .
Long-term mortality remains high in patients presenting with ACS despite advances in diagnosis and treatment. Therefore, identification of high-risk patients in this patient group is of prime importance. To date, various risk scores and biomarkers have been used for this purpose .
Albumin is the major protein in human plasma and the most abundant protein in the extracellular compartment. Albumin has multiple important physiological functions including maintenance of plasma osmotic pressure and capillary permeability, a ligand for many endogenous and exogenous compounds and it also affects the pharmacokinetics of several drugs .
In addition, low serum albumin is associated with increased adverse clinical outcomes and prognosis in cancer, heart failure, stroke, and stable coronary artery disease (CAD). Similarly, in patients with ACS, presence of hypoalbuminemia has been associated with increased severity of coronary lesions, no-reflow, increased in-hospital, and long-term mortality as well as development of heart failure .
Until now, several studies have documented the prognostic value of SA in patients with stable coronary artery disease (CAD), ST elevation myocardial infarction, and pulmonary embolism. In this research, the authors also concluded that admission SA level was a strong and independent predictor of all-cause long-term mortality in patients with ACS. Although the research was interesting and well-conducted, we have some comments .
Current European and North American guidelines recommend risk stratification of ACS cases using available risk scores, such as the thrombolysis in myocardial infarction (TIMI) score and the Global Registry of Acute Coronary Events (GRACE) score, to determine the in-hospital and 6-months risk of death and myocardial infarction in patients with ACS following an index event
. Beside that, a recent study revealed that these scores had an adequate predictive power for long-term mortality in patients who were diagnosed and hospitalized with ACS .
- Conditions
- Acute Coronary Syndrome
- Keywords
- Serum Albumin in Patients With Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Serum Albumin in Patients With Acute Coronary Syndrome
low serum albumin is associated with increased adverse clinical outcomes and prognosis in cancer, heart failure, stroke, and stable coronary artery disease (CAD). Similarly, in patients with ACS, presence of hypoalbuminemia has been associated with increased severity of coronary lesions, no-reflow, increased in-hospital, and long-term mortality as well as development of heart failure
Measured: 12 week after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Adel Zaki, Sohag University
- Investigators
- Osama A Arafa, Professor, Study director, Faculty of Medicine Sohag UniversityHamdy S Mohamed, A .Professor, Study director, Faculty of Medicine Sohag UniversityAhmed E Ebrahim, Lecturer, Study director, Faculty of Medicine Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727084
- Sponsor's protocol ID
- Soh-Med--24-11-04MS
- Status last verified
- Jul 2025
- First submitted
- 6 Dec 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chien SC, Chen CY, Leu HB, Su CH, Yin WH, Tseng WK, Wu YW, Lin TH, Chang KC, Wang JH, Wu CC, Yeh HI, Chen JW. Association of low serum albumin concentration and adverse cardiovascular events in stable coronary heart disease. Int J Cardiol. 2017 Aug 15;241:1-5. doi: 10.1016/j.ijcard.2017.04.003. Epub 2017 Apr 7.
PubMed 28413113Polat N, Oylumlu M, Isik MA, Arslan B, Ozbek M, Demir M, Kaya H, Toprak N. Prognostic Significance of Serum Albumin in Patients With Acute Coronary Syndrome. Angiology. 2020 Nov;71(10):903-908. doi: 10.1177/0003319720941747. Epub 2020 Jul 17.
PubMed 32677445D'Ascenzo F, Biondi-Zoccai G, Moretti C, Bollati M, Omede P, Sciuto F, Presutti DG, Modena MG, Gasparini M, Reed MJ, Sheiban I, Gaita F. TIMI, GRACE and alternative risk scores in Acute Coronary Syndromes: a meta-analysis of 40 derivation studies on 216,552 patients and of 42 validation studies on 31,625 patients. Contemp Clin Trials. 2012 May;33(3):507-14. doi: 10.1016/j.cct.2012.01.001. Epub 2012 Jan 11.
PubMed 22265976Zegre-Hemsey JK, Asafu-Adjei J, Fernandez A, Brice J. Characteristics of Prehospital Electrocardiogram Use in North Carolina Using a Novel Linkage of Emergency Medical Services and Emergency Department Data. Prehosp Emerg Care. 2019 Nov-Dec;23(6):772-779. doi: 10.1080/10903127.2019.1597230. Epub 2019 Apr 17.
PubMed 30885071
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Serum Albumin in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06727084
- Acronym / sponsor ID
- Soh-Med--24-11-04MS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Serum Albumin in Patients With Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 10 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.
Our study aims to investigate the predictive value of serum albumin and short-term mortality in patients with Acute Coronary Syndrome (ACS)
Detailed description
Acute coronary syndrome (ACS) refers to a group of conditions that include ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina. It is a type of coronary heart disease (CHD), which is responsible for one-third of total deaths in people older than 35. Some forms of CHD can be asymptomatic, but ACS is always symptomatic .
Long-term mortality remains high in patients presenting with ACS despite advances in diagnosis and treatment. Therefore, identification of high-risk patients in this patient group is of prime importance. To date, various risk scores and biomarkers have been used for this purpose .
Albumin is the major protein in human plasma and the most abundant protein in the extracellular compartment. Albumin has multiple important physiological functions including maintenance of plasma osmotic pressure and capillary permeability, a ligand for many endogenous and exogenous compounds and it also affects the pharmacokinetics of several drugs .
In addition, low serum albumin is associated with increased adverse clinical outcomes and prognosis in cancer, heart failure, stroke, and stable coronary artery disease (CAD). Similarly, in patients with ACS, presence of hypoalbuminemia has been associated with increased severity of coronary lesions, no-reflow, increased in-hospital, and long-term mortality as well as development of heart failure .
Until now, several studies have documented the prognostic value of SA in patients with stable coronary artery disease (CAD), ST elevation myocardial infarction, and pulmonary embolism. In this research, the authors also concluded that admission SA level was a strong and independent predictor of all-cause long-term mortality in patients with ACS. Although the research was interesting and well-conducted, we have some comments .
Current European and North American guidelines recommend risk stratification of ACS cases using available risk scores, such as the thrombolysis in myocardial infarction (TIMI) score and the Global Registry of Acute Coronary Events (GRACE) score, to determine the in-hospital and 6-months risk of death and myocardial infarction in patients with ACS following an index event
. Beside that, a recent study revealed that these scores had an adequate predictive power for long-term mortality in patients who were diagnosed and hospitalized with ACS .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who were admitted to the emergency department or coronary care unit with a diagnosis of acute coronary syndrome (ACS) will be eligible for inclusion.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older who were admitted to the emergency department or coronary care unit with a diagnosis of acute coronary syndrome (ACS) will be eligible for inclusion.
Key exclusion criteria (4 listed)
- Patients with a history of chronic liver disease, nephrotic syndrome, or other conditions known to affect serum albumin levels.
- Patients receiving albumin infusions or other treatments that could potentially interfere with serum albumin levels.
- Patients with incomplete medical records or missing laboratory data.
- Patients who declined to participate in the study.
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
Value of Serum Albumin in Patients With Acute Coronary Syndrome
Time frame: 12 week after the end of treatment
low serum albumin is associated with increased adverse clinical outcomes and prognosis in cancer, heart failure, stroke, and stable coronary artery disease (CAD). Similarly, in patients with ACS, presence of hypoalbuminemia has been associated with increased severity of coronary lesions, no-reflow, increased in-hospital, and long-term mortality as well as development of heart failure
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 4 Jul 2025.
- Background: PubMed 28413113Chien SC, Chen CY, Leu HB, Su CH, Yin WH, Tseng WK, Wu YW, Lin TH, Chang KC, Wang JH, Wu CC, Yeh HI, Chen JW. Association of low serum albumin concentration and adverse cardiovascular events in stable coronary heart disease. Int J Cardiol. 2017 Aug 15;241:1-5. doi: 10.1016/j.ijcard.2017.04.003. Epub 2017 Apr 7.
- Background: PubMed 32677445Polat N, Oylumlu M, Isik MA, Arslan B, Ozbek M, Demir M, Kaya H, Toprak N. Prognostic Significance of Serum Albumin in Patients With Acute Coronary Syndrome. Angiology. 2020 Nov;71(10):903-908. doi: 10.1177/0003319720941747. Epub 2020 Jul 17.
- Background: PubMed 22265976D'Ascenzo F, Biondi-Zoccai G, Moretti C, Bollati M, Omede P, Sciuto F, Presutti DG, Modena MG, Gasparini M, Reed MJ, Sheiban I, Gaita F. TIMI, GRACE and alternative risk scores in Acute Coronary Syndromes: a meta-analysis of 40 derivation studies on 216,552 patients and of 42 validation studies on 31,625 patients. Contemp Clin Trials. 2012 May;33(3):507-14. doi: 10.1016/j.cct.2012.01.001. Epub 2012 Jan 11.
- Background: PubMed 30885071Zegre-Hemsey JK, Asafu-Adjei J, Fernandez A, Brice J. Characteristics of Prehospital Electrocardiogram Use in North Carolina Using a Novel Linkage of Emergency Medical Services and Emergency Department Data. Prehosp Emerg Care. 2019 Nov-Dec;23(6):772-779. doi: 10.1080/10903127.2019.1597230. Epub 2019 Apr 17.
- Individual participant dataSharing planned: No
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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.
Osama A Arafa, Professor study director
Faculty of Medicine Sohag University
Hamdy S Mohamed, A .Professor study director
Faculty of Medicine Sohag University
Ahmed E Ebrahim, Lecturer study director
Faculty of Medicine Sohag University
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, run by Sohag University at 1 site in Egypt.
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 4 Jul 2025. 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 Egypt. 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?
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 Magdy A Zaky, Resident (2011 29226770, magdyadel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of Serum Albumin in Patients With Acute Coronary Syndrome (time frame: 12 week after the end of treatment). 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 NCT06727084, which also lists 4 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 4 Jul 2025.