Endothelial Microparticles as Potential Biomarkers of Endothelial Dysfunction

NCT04512404 | Completed

• 1 other identifier: 1001/PPSP/812211
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• EMP level and its correlation with endothelial function by pulse wave analysis

  EMP level: absolute count Endothelial function by pulse wave analysis

  1 day (First visit)

• EMP level and its correlation with endothelial function by pulse wave analysis

  EMP level: absolute count Endothelial function by pulse wave analysis

  3 months (Fourth visit)

Study Arms (1)

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

Drug: HMG-CoA Reductase Inhibitor

Interventions

HMG-CoA Reductase Inhibitor DRUG

Also known as: statin

hypercholesterolemia

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed hypercholesterolemia

You may qualify if:

• Hypercholesterolaemia: ( LDL \>4.1 mmol/l)
• Age 35 years and above
• Agreeable to the treatment with statin if indicated

You may not qualify if:

• Pregnancy and breast feeding
• Serious medical illness eg kidney failure, liver failure, stroke and malignancy.
• Arrythmias
• Contraindicated to statin

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• NIk Ibrahim

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 13, 2020
• Study Start: October 13, 2016
• Primary Completion: October 31, 2021
• Study Completion: May 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

MY (1)