- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06757777
Evaluation of Remnant Cholesterol Levels and Monocyte-to-HDL-cholesterol Ratio As Predictors of Coronary Artery Disease Severity in Patients with Acute Coronary Syndrome
- Evaluation of serum level of remnant cholesterol and monocyte/HDL ratio as predictors of severity of coronary artery disease in patients with acute coronary syndrome.
- Evaluate predictive value of remnant cholesterol serum level and monocyte/HDL ratio to detect in-hospital worse clinical outcomes and 45 days major adverse cardiac events (MACE) after acute coronary syndrome.
Study Overview
Status
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), ACS is the most common cause of death in patients with CAD and it is estimated that about 661,000 people in the United States suffer from ACS in 2016 ,which highlights the importance of risk assessment for ACS.
Elevated remnant cholesterol, including cholesterol carried in VLDL and chylomicron remnants, is emerging as a causal risk factor for ASCV in addition to elevated LDL-cholesterol ,Studies of the general population have shown that risk of myocardial infarction, ischemic stroke and peripheral artery disease is increased in individuals with elevated remnant cholesterol. High-density lipoprotein-cholesterol (HDL-C) exhibits anti-atherosclerotic effects by neutralizing the pro-inflammatory and pro-oxidant effects of monocytes via inhibiting the migration of macrophages and LDL oxidation in addition to the efflux of cholesterol from these cells. Furthermore, HDL plays a role in suppressing the activation of monocytes and proliferation-differentiation of monocyte progenitor cells. Thus, accumulation of monocytes and reduction of HDL-C may participate in atherosclerosis and cardiovascular diseases (CVD) .
Global Registry of Acute Coronary Events (GRACE) score is a risk assessment system for ACS based on risk factors summarized from clinical cases.
The Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a scoring system for risk stratification based on the anatomical characteristics of coronary artery lesions to help cardiologists, interventionists and surgeons to grade the complexity of coronary artery lesions .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Isaac A Ghaly, Resident
- Phone Number: +201201979010
- Email: ishaq.16287235@med.aun.edu.eg
Study Contact Backup
- Name: Hanan A Mahmoud, Lecturer
- Phone Number: 01065735355
- Email: drhanan_abuelrus@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with acute coronary syndrome presented to ER of Assiut university hospital scheduled for primary PCI and able to provide informed consent.
Exclusion Criteria:
- Patients on previous statin therapy.
- Patients with severe renal dysfunction (creatinine clearance <30 mL/min) or other contraindications to PCI.
- Patients with missed data or who couldn't be followed up
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of serum level of remnant cholesterol and monocyte/HDL ratio as predictors of severity of coronary artery disease in patients with acute coronary syndrome.
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate predictive value of remnant cholesterol serum level and monocyte/HDL ratio to detect in-hospital worse clinical outcomes and 45 days major adverse cardiac events (MACE) after acute coronary syndrome.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isaac A Ghaly, Resident, Assiut University
- Study Director: Hanan A Mahmoud, Lecturer, Assiut University
- Study Director: Khaled A Mohamed, Lecturer, Assiut University
Publications and helpful links
General Publications
- Zegre-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.
- Wadstrom BN, Wulff AB, Pedersen KM, Jensen GB, Nordestgaard BG. Elevated remnant cholesterol increases the risk of peripheral artery disease, myocardial infarction, and ischaemic stroke: a cohort-based study. Eur Heart J. 2022 Sep 7;43(34):3258-3269. doi: 10.1093/eurheartj/ehab705.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Monocyte to HDL Cholest. Ratio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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