Endothelial DysfunctionNCT04512404
Endothelial Microparticles as Potential Biomarkers of Endothelial Dysfunction
An observational study of Endothelial Dysfunction, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- HMG-CoA Reductase Inhibitor
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Oct 2016to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed hypercholesterolemia
Who may be able to join
- Hypercholesterolaemia: ( LDL >4.1 mmol/l)
- Age 35 years and above
- Agreeable to the treatment with statin if indicated
Who cannot join
- Pregnancy and breast feeding
- Serious medical illness eg kidney failure, liver failure, stroke and malignancy.
- Arrythmias
- Contraindicated to statin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Microparticles as Potential Biomarkers for Endothelial Dysfunction in Hypercholesterolemia and Its Correlation With Pulse Wave Analysis
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.
Read the 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
It is a clinical cohort study involving newly diagnosed hypercholesterolemic patients before and after intervention with statin.
Sampling method and subject recruitment Consecutive sampling of sampling frame will be applied due to limited number of sample who could fulfill the criteria within the planned data collection period.
Data collection method
Screening
Before acceptance into the study, all potential subjects will undergo a screening procedure. A signed written informed consent will be obtained from the subjects before screening procedure is performed. The screening procedure will include detailed history taking on medical history, physical examination and 5 ml venous blood sampling for fasting lipid profile (FLP) from the antecubital vein.
Clinical study session
Once the FLP results are obtained, appointment to attend the clinical study sessions will be arranged with the eligible subjects who fulfil the criteria.
Newly diagnosed hypercholesterolaemia patients recruited will undergo clinical study.
First visit
The first visit will involve blood taking for baseline values, assessment with SphygmoCor and consultation by the treating physician.
During the first visit, 10 ml of venous blood will be withdrawn from the antecubital vein followed by the assessment of endothelial function, augmentation index (AI) and central arterial pressure (CAP) using SphygmoCor.
Venous blood is needed for baseline full blood count (FBC), renal function test (RFT), liver function test (LFT), fasting blood sugar (FBS), high sensitivity C-reactive protein (hs-CRP) and EMP.
Assessment of endothelial function, AI and CAP using SphygmoCor .
Physician consultation
During the first visit, all patients will be seen by the treating physician (a Family Medicine Specialist) at the outpatient clinic (KRK) and advised for therapeutic life style changes (TLC) as recommended by the Malaysian Clinical Practice Guideline (CPG) for Hyperlipidaemia (2011). Patients will be on TLC for a minimum duration of 6 weeks before the next visit.
Second visit
The second visit will only involve blood taking for FLP (5 ml blood) after at least 6 weeks duration of TLC.
Third visit
Once the FLP results are obtained (in approximately a week), patients will then be seen by the treating physician in the clinic.
Patients who do not achieve the targeted LDL level after TLC and indicated for treatment will be prescribed with statin by the attending physician.
Patients who achieve the targeted LDL level after TLC will continue TLC and will be excluded from the study
Fourth visit
The fourth visit will be arranged with the patients 3 months later. 10 ml of blood will be withdrawn for EMP quantification, FLP, hs-CRP and LFT. This will be followed by the assessments of endothelial function, AI and CAP as explained above.
Fourth visit marks the end of the Study 2. Thereafter, patients will continue their treatment at the KRK.
The study duration for each subject will be approximately 5 months.
Patients that miss follow-up or not compliant to the medication prescribed will be excluded from the study analysis. However, this will not compromise the treatment received by patients as they will continue to be treated in KRK.
- Conditions
- Endothelial Dysfunction
- Being tested
- HMG-CoA Reductase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMG-CoA Reductase InhibitorDrug
Also called statin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HMG-CoA Reductase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMP level and its correlation with endothelial function by pulse wave analysis
EMP level: absolute count Endothelial function by pulse wave analysis
Measured: 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
Measured: 3 months (Fourth visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start13 Oct 2016
- Primary completion31 Oct 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nik Nor Izah Nik Ibrahim, Universiti Sains Malaysia
- Investigators
- NIk Ibrahim, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512404
- Sponsor's protocol ID
- 1001/PPSP/812211
- Status last verified
- Nov 2022
- First submitted
- 5 Aug 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Microparticles as Potential Biomarkers for Endothelial Dysfunction in Hypercholesterolemia and Its Correlation With Pulse Wave Analysis
- ClinicalTrials.gov ID
- NCT04512404
- Acronym / sponsor ID
- 1001/PPSP/812211
- Conditions
- Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
It is a clinical cohort study involving newly diagnosed hypercholesterolemic patients before and after intervention with statin.
Sampling method and subject recruitment Consecutive sampling of sampling frame will be applied due to limited number of sample who could fulfill the criteria within the planned data collection period.
Data collection method
Screening
Before acceptance into the study, all potential subjects will undergo a screening procedure. A signed written informed consent will be obtained from the subjects before screening procedure is performed. The screening procedure will include detailed history taking on medical history, physical examination and 5 ml venous blood sampling for fasting lipid profile (FLP) from the antecubital vein.
Clinical study session
Once the FLP results are obtained, appointment to attend the clinical study sessions will be arranged with the eligible subjects who fulfil the criteria.
Newly diagnosed hypercholesterolaemia patients recruited will undergo clinical study.
First visit
The first visit will involve blood taking for baseline values, assessment with SphygmoCor and consultation by the treating physician.
During the first visit, 10 ml of venous blood will be withdrawn from the antecubital vein followed by the assessment of endothelial function, augmentation index (AI) and central arterial pressure (CAP) using SphygmoCor.
Venous blood is needed for baseline full blood count (FBC), renal function test (RFT), liver function test (LFT), fasting blood sugar (FBS), high sensitivity C-reactive protein (hs-CRP) and EMP.
Assessment of endothelial function, AI and CAP using SphygmoCor .
Physician consultation
During the first visit, all patients will be seen by the treating physician (a Family Medicine Specialist) at the outpatient clinic (KRK) and advised for therapeutic life style changes (TLC) as recommended by the Malaysian Clinical Practice Guideline (CPG) for Hyperlipidaemia (2011). Patients will be on TLC for a minimum duration of 6 weeks before the next visit.
Second visit
The second visit will only involve blood taking for FLP (5 ml blood) after at least 6 weeks duration of TLC.
Third visit
Once the FLP results are obtained (in approximately a week), patients will then be seen by the treating physician in the clinic.
Patients who do not achieve the targeted LDL level after TLC and indicated for treatment will be prescribed with statin by the attending physician.
Patients who achieve the targeted LDL level after TLC will continue TLC and will be excluded from the study
Fourth visit
The fourth visit will be arranged with the patients 3 months later. 10 ml of blood will be withdrawn for EMP quantification, FLP, hs-CRP and LFT. This will be followed by the assessments of endothelial function, AI and CAP as explained above.
Fourth visit marks the end of the Study 2. Thereafter, patients will continue their treatment at the KRK.
The study duration for each subject will be approximately 5 months.
Patients that miss follow-up or not compliant to the medication prescribed will be excluded from the study analysis. However, this will not compromise the treatment received by patients as they will continue to be treated in KRK.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypercholesterolemia | – | Drug: HMG-CoA Reductase Inhibitor3-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 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed hypercholesterolemia
Key inclusion criteria (3 listed)
- Hypercholesterolaemia: ( LDL >4.1 mmol/l)
- Age 35 years and above
- Agreeable to the treatment with statin if indicated
Key exclusion criteria (4 listed)
- Pregnancy and breast feeding
- Serious medical illness eg kidney failure, liver failure, stroke and malignancy.
- Arrythmias
- Contraindicated to statin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMG-CoA Reductase InhibitorAlso: statin | Drug | hypercholesterolemia |
Primary outcome
EMP level and its correlation with endothelial function by pulse wave analysis
Time frame: 1 day (First visit)
EMP level: absolute count Endothelial function by pulse wave analysis
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Related trials for Endothelial Dysfunction
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NIk Ibrahim principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMP level and its correlation with endothelial function by pulse wave analysis (time frame: 1 day (First visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.