- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507110
Relationship Between RAR and MACEs in AMI-CS Patients During Hospitalization
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Xuzhou, China
- Xuzhou Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AMI-CS
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
individual components of MACEs
Time Frame: up to 1 month
|
up to 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XZXY-LJ-20210715-056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction (AMI)
-
National University Heart Centre, SingaporeActive, not recruitingAcute Myocardial Infarction (AMI)Singapore
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingAcute Myocardial Infarction (AMI)China
-
Shanghai Zhongshan HospitalRecruiting
-
The Affiliated Hospital of Xuzhou Medical UniversityActive, not recruiting
-
October 6 UniversityMansoura UniversityRecruitingAcute Myocardial Infarction (AMI)Egypt
-
Beijing Anzhen HospitalNot yet recruitingAcute Myocardial Infarction (AMI)
-
Shanghai Zhongshan HospitalRecruitingAcute Myocardial Infarction (AMI)China
-
Rohan DharmakumarIndiana UniversityCompletedAcute Myocardial Infarction (AMI)United States
-
Guangdong Provincial People's HospitalActive, not recruitingElectrocardiography | Acute Myocardial Infarction (AMI) | Artifical IntelligenceChina
-
Shanghai Hutchison Pharmaceuticals LimitedThe First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsNot yet recruitingAcute Myocardial Infarction (AMI) | Percutaneous Coronary Intervention (PCI)China
Clinical Trials on Includ the inclusion/exclusion criteria of AMI-CS
-
Zimmer BiometCompletedRheumatoid Arthritis | Osteonecrosis | Osteoarthritis, Hip | Post-traumatic; Arthrosis | Fracture of Hip | Dislocated Hip | Subluxation Hip
-
Spinal Stabilization TechnologiesTerminatedChronic Low-back Pain | Degenerative Disc DiseaseParaguay
-
Cairo UniversityCompletedAssessment of Torso Musculature and Hamstring Flexibility in Patients With Chronic Ankle InstabilityChronic Ankle Instability, CAIEgypt
-
Centre Hospitalier Intercommunal CreteilNot yet recruiting
-
Beni-Suef UniversityCompleted
-
Assiut UniversityNot yet recruiting