Red Blood Cell Distribution Width-to-albumin RatioNCT07507110
Relationship Between RAR and MACEs in AMI-CS Patients During Hospitalization
An observational study of Red Blood Cell Distribution Width-to-albumin Ratio and Acute Myocardial Infarction (AMI), run by Xuzhou Central Hospital at 1 site in China.
Trial summary
This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Acute myocardial infarction (AMI) were screened and AMI complicating with cardiogenic shock were included. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Red Blood Cell Distribution Width-to-albumin Ratio, Acute Myocardial Infarction (AMI), Major Adverse Cardiovascular Events
- What is being tested?
- Includ the inclusion/exclusion criteria of AMI-CS
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Dec 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Between January 2019 and December 2024, a total of 3316 patients diagnosed with AMI were screened. Among them, 264 cases complicating with cardiogenic shock were included.
Who may be able to join
- Age over 18 years and under 90 years;
- Meeting the diagnostic criteria for acute myocardial infarction: myocardial injury markers (preferably troponin) ≥ 99th percentile of the upper limit of normal value, combined with at least one evidence of myocardial ischemia: persistent myocardial ischemic symptoms ≥ 30 minutes; accompanied by ST-segment elevation or depression on electrocardiogram;
- Meeting the diagnostic criteria for cardiogenic shock: systolic blood pressure < 90 mmHg, accompanied by clinical symptoms of pulmonary congestion such as dyspnea, and at least one of the following peripheral organ perfusion impairments: altered mental status; cold and clammy skin; urine output < 30 ml/h; or serum lactate level > 2.0 mmol/L.
Who cannot join
- Coexisting cerebrovascular disease, peripheral vascular disease or embolic disease;
- Myocardial infarction caused by coronary artery embolism or blood flow interruption due to peripheral embolus detachment or invasive diagnostic and therapeutic procedures;
- History of surgery, trauma or infection within one month;
- History of severe liver or kidney dysfunction, , including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ-glutamyl transpeptidase (γ-GGT) > 2.5 times upper limit of normal value; Serum creatinine > 1.5 times upper limit of normal value;
- Coexisting autoimmune diseases, tumors, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Red Blood Cell Distribution Width-to-albumin Ratio and Major Adverse Cardiovascular Events in Acute Myocardial Infarction Complicated With Cardiogenic Shock Patients During Hospitalization
This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Acute myocardial infarction (AMI) were screened and AMI complicating with cardiogenic shock were included. This study is to investigate the relationship between red blood cell distribution width-to-albumin ratio (RAR) and major adverse cardiovascular events (MACEs) in acute myocardial infarction complicated with cardiogenic shock (AMI-CS) patients during hospitalization.
Read the detailed description
Coronary atherosclerotic heart disease is still the leading cause of death worldwide]. Studies show that the mortality and morbidity of acute myocardial infarction (AMI) in China are increasing year by year, which has brought significant burdens both in healthcare and economy of society. Although modified treatment and early reperfusion therapy can significantly reduce the mortality rate of patients with AMI, the in-hospital mortality rate still exceed over 4%. The high mortality in AMI is related to complications such as acute heart failure, malignant arrhythmia, cardiac rupture, and cardiogenic shock. Among them, cardiogenic shock is one of the most serious complications of AMI. Nearly 5% of patients with AMI develop cardiogenic shock during hospitalization. Moreover, the all-cause mortality of patients with cardiogenic shock significantly increases within 60 days, and the mortality rate of patients remain at high risk in long term.
Understanding the relevant factors and predictive indicators of AMI can provide valuable treatment strategies and prognosis information for clinicians, patients and their families. Current prognostic biomarkers have some limitations, such as high cost, long waiting time for test results and could not predicting outcomes accurately. Therefore, discovering a convenient and effective biomarker to predict the prognosis of acute myocardial infarction complicated with cardiogenic shock (AMI-CS) patients is very important. It could help us identify high-risk in these patients to potentially guide therapy strategy and patient management.
Red blood cell distribution width (RDW) is a biomarker reflecting the variation in red blood cell volume in human blood circulation. Previous studies have shown that an elevated RDW is closely associated with cardiovascular diseases, such as acute coronary syndromes, heart failure, etc. And it has emerged as a promising biomarker reflecting underlying inflammatory and oxidative stress processes in cardiovascular diseases. Previous studies shows that RDW was independently associated with an increased mortality rate in patients with AMI six months later and a long-term all-cause mortality rate increase in STEMI patients after revascularization. Recently, some recommendations have indicated that the combination of RDW with certain biomarkers may be more valuable for disease prognosis.
Albumin is a crucial protein in the human blood circulation system and is often used as a marker for nutritional status and overall health and it has been shown to be associated with reduction of oxidative stress and anti-inflammatory activity. And low serum albumin levels are associated with poor prognosis in cardiovascular diseases, which may indicate chronic inflammation and malnutrition. Recent studies have demonstrated that low albumin level is a significant predictor of poor prognosis in patients with AMI.
Given RDW and albumin have been individually linked to adverse cardiovascular outcomes, their combined marker, the red cell distribution width-to-albumin ratio (RAR), which has shown a potential prognostic value in AMI but not be fully explored. RAR may provide a more comprehensive assessment of AMI patient risks and help identify high-risk AMI patients who may benefit from more proactive intervention measures during hospitalization. Given the prognostic value of RAR on AMI-CS patients in short term is still unclear; this study is to investigate the relationship between RAR and major adverse cardiovascular events (MACEs) in AMI-CS patients during hospitalization.
- Conditions
- Red Blood Cell Distribution Width-to-albumin Ratio, Acute Myocardial Infarction (AMI), Major Adverse Cardiovascular Events
- Being tested
- Includ the inclusion/exclusion criteria of AMI-CS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Includ the inclusion/exclusion criteria of AMI-CSDiagnostic test
he inclusion criteria were as follows: (1) Age over 18 years and under 90 years; (2) Meeting the diagnostic criteria for acute myocardial infarction[16]: myocardial injury markers (preferably troponin) ≥ 99th percentile of the upper limit of normal value, combined with at least one evidence of myocardial ischemia: persistent myocardial ischemic symptoms ≥ 30 minutes; accompanied by ST-segment elevation or depression on electrocardiogram; (3) Meeting the diagnostic criteria for cardiogenic shock[17]: systolic blood pressure < 90 mmHg, accompanied by clinical symptoms of pulmonary congestion such as dyspnea, and at least one of the following peripheral organ perfusion impairments: altered mental status; cold and clammy skin; urine output < 30 ml/h; or serum lactate level > 2.0 mmol/L. The exclusion criteria included: (1) Coexisting cerebrovascular disease, peripheral vascular disease or embolic disease; (2) Myocardial infarction caused by coronary artery embolism or blood flow interrupti
| Study group | Role | What they receive |
|---|---|---|
| AMI-CS | Not described Receives: Diagnostic Test: Includ the inclusion/exclusion criteria of AMI-CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of major adverse cardiovascular events (MACEs) during hospitalization.
Include all-cause death, recurrent non-fatal myocardial infarction, unplanned revascularization, and non-fatal stroke.
Measured: up to 1 month
Secondary outcomes (1)
individual components of MACEs
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jul 2019
- Primary completion31 Oct 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cell Distribution Width-to-albumin RatioStudies 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
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenpengsheng, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507110
- Sponsor's protocol ID
- XZXY-LJ-20210715-056
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, Wang T, Huang Y, Li X, Han B, Chen P. Red blood cell distribution width-to-albumin ratio and in-hospital major adverse cardiovascular events in patients with acute myocardial infarction complicated by cardiogenic shock: a two-center retrospective cohort study. Front Cardiovasc Med. 2026 Aug 3;13:1866356. doi: 10.3389/fcvm.2026.1866356. eCollection 2026.
PubMed 42609300
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Red Blood Cell Distribution Width-to-albumin Ratio and Major Adverse Cardiovascular Events in Acute Myocardial Infarction Complicated With Cardiogenic Shock Patients During Hospitalization
- ClinicalTrials.gov ID
- NCT07507110
- Acronym / sponsor ID
- XZXY-LJ-20210715-056
- Conditions
- Red Blood Cell Distribution Width-to-albumin Ratio, Acute Myocardial Infarction (AMI), Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Apr 2026 (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.
This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Acute myocardial infarction (AMI) were screened and AMI complicating with cardiogenic shock were included. This study is to investigate the relationship between red blood cell distribution width-to-albumin ratio (RAR) and major adverse cardiovascular events (MACEs) in acute myocardial infarction complicated with cardiogenic shock (AMI-CS) patients during hospitalization.
Detailed description
Coronary atherosclerotic heart disease is still the leading cause of death worldwide]. Studies show that the mortality and morbidity of acute myocardial infarction (AMI) in China are increasing year by year, which has brought significant burdens both in healthcare and economy of society. Although modified treatment and early reperfusion therapy can significantly reduce the mortality rate of patients with AMI, the in-hospital mortality rate still exceed over 4%. The high mortality in AMI is related to complications such as acute heart failure, malignant arrhythmia, cardiac rupture, and cardiogenic shock. Among them, cardiogenic shock is one of the most serious complications of AMI. Nearly 5% of patients with AMI develop cardiogenic shock during hospitalization. Moreover, the all-cause mortality of patients with cardiogenic shock significantly increases within 60 days, and the mortality rate of patients remain at high risk in long term.
Understanding the relevant factors and predictive indicators of AMI can provide valuable treatment strategies and prognosis information for clinicians, patients and their families. Current prognostic biomarkers have some limitations, such as high cost, long waiting time for test results and could not predicting outcomes accurately. Therefore, discovering a convenient and effective biomarker to predict the prognosis of acute myocardial infarction complicated with cardiogenic shock (AMI-CS) patients is very important. It could help us identify high-risk in these patients to potentially guide therapy strategy and patient management.
Red blood cell distribution width (RDW) is a biomarker reflecting the variation in red blood cell volume in human blood circulation. Previous studies have shown that an elevated RDW is closely associated with cardiovascular diseases, such as acute coronary syndromes, heart failure, etc. And it has emerged as a promising biomarker reflecting underlying inflammatory and oxidative stress processes in cardiovascular diseases. Previous studies shows that RDW was independently associated with an increased mortality rate in patients with AMI six months later and a long-term all-cause mortality rate increase in STEMI patients after revascularization. Recently, some recommendations have indicated that the combination of RDW with certain biomarkers may be more valuable for disease prognosis.
Albumin is a crucial protein in the human blood circulation system and is often used as a marker for nutritional status and overall health and it has been shown to be associated with reduction of oxidative stress and anti-inflammatory activity. And low serum albumin levels are associated with poor prognosis in cardiovascular diseases, which may indicate chronic inflammation and malnutrition. Recent studies have demonstrated that low albumin level is a significant predictor of poor prognosis in patients with AMI.
Given RDW and albumin have been individually linked to adverse cardiovascular outcomes, their combined marker, the red cell distribution width-to-albumin ratio (RAR), which has shown a potential prognostic value in AMI but not be fully explored. RAR may provide a more comprehensive assessment of AMI patient risks and help identify high-risk AMI patients who may benefit from more proactive intervention measures during hospitalization. Given the prognostic value of RAR on AMI-CS patients in short term is still unclear; this study is to investigate the relationship between RAR and major adverse cardiovascular events (MACEs) in AMI-CS patients during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI-CS | – | Diagnostic Test: Includ the inclusion/exclusion criteria of AMI-CS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Between January 2019 and December 2024, a total of 3316 patients diagnosed with AMI were screened. Among them, 264 cases complicating with cardiogenic shock were included.
Key inclusion criteria (3 listed)
- Age over 18 years and under 90 years;
- Meeting the diagnostic criteria for acute myocardial infarction: myocardial injury markers (preferably troponin) ≥ 99th percentile of the upper limit of normal value, combined with at least one evidence of myocardial ischemia: persistent myocardial ischemic symptoms ≥ 30 minutes; accompanied by ST-segment elevation or depression on electrocardiogram;
- Meeting the diagnostic criteria for cardiogenic shock: systolic blood pressure < 90 mmHg, accompanied by clinical symptoms of pulmonary congestion such as dyspnea, and at least one of the following peripheral organ perfusion impairments: altered mental status; cold and clammy skin; urine output < 30 ml/h; or serum lactate level > 2.0 mmol/L.
Key exclusion criteria (5 listed)
- Coexisting cerebrovascular disease, peripheral vascular disease or embolic disease;
- Myocardial infarction caused by coronary artery embolism or blood flow interruption due to peripheral embolus detachment or invasive diagnostic and therapeutic procedures;
- History of surgery, trauma or infection within one month;
- History of severe liver or kidney dysfunction, , including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ-glutamyl transpeptidase (γ-GGT) > 2.5 times upper limit of normal value; Serum creatinine > 1.5 times upper limit of normal value;
- Coexisting autoimmune diseases, tumors, etc.
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 |
|---|---|---|
| Includ the inclusion/exclusion criteria of AMI-CShe inclusion criteria were as follows: (1) Age over 18 years and under 90 years; (2) Meeting the diagnostic criteria for acute myocardial infarction[16]: myocardial injury markers (preferably troponin) ≥ 99th percentile of the upper limit of normal value, combined with at least one evidence of myocardial ischemia: persistent myocardial ischemic symptoms ≥ 30 minutes; accompanied by ST-segment elevation or depression on electrocardiogram; (3) Meeting the diagnostic criteria for cardiogenic shock[17]: systolic blood pressure < 90 mmHg, accompanied by clinical symptoms of pulmonary congestion such as dyspnea, and at least one of the following peripheral organ perfusion impairments: altered mental status; cold and clammy skin; urine output < 30 ml/h; or serum lactate level > 2.0 mmol/L. The exclusion criteria included: (1) Coexisting cerebrovascular disease, peripheral vascular disease or embolic disease; (2) Myocardial infarction caused by coronary artery embolism or blood flow interrupti | Diagnostic test | AMI-CS |
Primary outcome
the occurrence of major adverse cardiovascular events (MACEs) during hospitalization.
Time frame: up to 1 month
Include all-cause death, recurrent non-fatal myocardial infarction, unplanned revascularization, and non-fatal stroke.
1 secondary outcome
individual components of MACEs
Time frame: up to 1 month
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 2 Apr 2026.
- Derived from this study: PubMed 42609300Liu J, Wang T, Huang Y, Li X, Han B, Chen P. Red blood cell distribution width-to-albumin ratio and in-hospital major adverse cardiovascular events in patients with acute myocardial infarction complicated by cardiogenic shock: a two-center retrospective cohort study. Front Cardiovasc Med. 2026 Aug 3;13:1866356. doi: 10.3389/fcvm.2026.1866356. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Red Blood Cell Distribution Width-to-albumin Ratio and Acute Myocardial Infarction (AMI), run by Xuzhou Central Hospital at 1 site in China.
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 3 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 2 Apr 2026. 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 China. 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?
the occurrence of major adverse cardiovascular events (MACEs) during hospitalization. (time frame: up to 1 month). 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 NCT07507110, which also lists 1 linked publication.
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 2 Apr 2026; AzTrials last refreshed its copy on 5 Nov 2026.