Endothelial Microparticles as Potential Biomarkers for Endothelial Dysfunction in Hypercholesterolemia and Its Correlation With Pulse Wave Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- EMP level and its correlation with endothelial function by pulse wave analysis
Study Overview
Brief Summary
Endothelial microparticles (EMP) have a promising role as a diagnostic and prognostic tool in the assessment of endothelial function. This study compares the levels of EMP in hypercholesterolaemia patients before and after treatment with statins and correlates it with the current method of assessing endothelial function using pulse wave analysis.
The current available methods to assess endothelial function are tedious and not suitable to be applied clinically. Detecting EMP levels are simpler as it only involves routine blood taking which is better tolerated by patients.
Outcome from this study will contribute to finding a potential diagnostic, prognostic and treatment assessment tool that is suitable to be used clinically. This will have a large impact in the management of cardiovascular-related disease that is prevalent worldwide and increasing in the developed countries.
Detailed Description
General study objective
To evaluate EMP as a simple diagnostic tool in assessing endothelial function in hypercholesterolaemic patients.
Specific objectives:
- To compare the levels of EMP ( Cluster of differentiation (CD)144, CD62e and CD31+/42-) in hypercholesterolaemics before and after statin.
- To correlate the levels of EMP with the assessment of endothelial function using pulse wave analysis (PWA) in hypercholesterolaemics before and after statin.
Research design
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hypercholesterolaemia: ( LDL >4.1 mmol/l)
- •Age 35 years and above
- •Agreeable to the treatment with statin if indicated
Exclusion Criteria
- •Pregnancy and breast feeding
- •Serious medical illness eg kidney failure, liver failure, stroke and malignancy.
- •Contraindicated to statin
Arms & Interventions
hypercholesterolemia
3-hydroxy-3-methylglutaric acid coenzyme A (HMG Co-A) reductase inhibitor Types of drug, dosage and frequency is according to the treating physician. This is an observational study.
Duration of treatment: 3-5 months
Intervention: HMG-CoA Reductase Inhibitor (Drug)
Outcomes
Primary Outcomes
EMP level and its correlation with endothelial function by pulse wave analysis
Time Frame: 3 months (Fourth visit)
EMP level: absolute count Endothelial function by pulse wave analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Nik Nor Izah Nik Ibrahim
Principal Investigator
Universiti Sains Malaysia