Acute Coronary SyndromeNCT06757777
Evaluation of Remnant Cholesterol Levels and Monocyte-to-HDL-cholesterol Ratio as Predictors of Coronary Artery Disease Severity in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and ACS (Acute Coronary Syndrome), run by Assiut University.
Trial summary
1. 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. 2. Evaluate predictive value of remnant cholesterol serum level and monocyte/HDL ratio to detect in-hospital worse clinical outcomes and 45 days… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Coronary Syndrome, ACS (Acute Coronary Syndrome), Monocyte to HDL Cholesterol Ratio
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2025to 8 Mar 2026
- Phase
- Observational
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 65 years
- All sexes
- Adult, Older adult
Study population: Patients with acute coronary syndrome presented to ER of Assiut university hospital scheduled for primary PCI and able to provide informed consent
Who may be able to join
- Patients with acute coronary syndrome presented to ER of Assiut university hospital scheduled for primary PCI and able to provide informed consent.
Who cannot join
- 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
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
- 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.
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), 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 .
- Conditions
- Acute Coronary Syndrome, ACS (Acute Coronary Syndrome), Monocyte to HDL Cholesterol Ratio, STEMI, Non STEMI
- Keywords
- Acs, Acute coronary syndrome, STEMI, NON STEMI, Monocyte/HDL Ratio
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start8 Feb 2025 (estimated)
- Primary completion8 Feb 2026 (estimated)
- Study completion8 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 SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaac Ghaly Tawfik Girgis, Assiut University
- Investigators
- Isaac A Ghaly, Resident, Principal investigator, Assiut UniversityHanan A Mahmoud, Lecturer, Study director, Assiut UniversityKhaled A Mohamed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757777
- Sponsor's protocol ID
- Monocyte to HDL Cholest. Ratio
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34661640Zegre-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