Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-28 @ 2:46 PM
Study NCT ID:
NCT04512404
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2020-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Microparticles as Potential Biomarkers of Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EMP level and its correlation with endothelial function by pulse wave analysis', 'timeFrame': '1 day (First visit)', 'description': 'EMP level: absolute count Endothelial function by pulse wave analysis'}, {'measure': 'EMP level and its correlation with endothelial function by pulse wave analysis', 'timeFrame': '3 months (Fourth visit)', 'description': 'EMP level: absolute count Endothelial function by pulse wave analysis'}]}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nOutcome 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.', 'detailedDescription': 'General study objective\n\nTo evaluate EMP as a simple diagnostic tool in assessing endothelial function in hypercholesterolaemic patients.\n\nSpecific objectives:\n\n1. To compare the levels of EMP ( Cluster of differentiation (CD)144, CD62e and CD31+/42-) in hypercholesterolaemics before and after statin.\n2. To correlate the levels of EMP with the assessment of endothelial function using pulse wave analysis (PWA) in hypercholesterolaemics before and after statin.\n\nResearch design\n\nIt is a clinical cohort study involving newly diagnosed hypercholesterolemic patients before and after intervention with statin.\n\nSampling 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.\n\nData collection method\n\nScreening\n\nBefore 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.\n\nClinical study session\n\nOnce the FLP results are obtained, appointment to attend the clinical study sessions will be arranged with the eligible subjects who fulfil the criteria.\n\nNewly diagnosed hypercholesterolaemia patients recruited will undergo clinical study.\n\nFirst visit\n\nThe first visit will involve blood taking for baseline values, assessment with SphygmoCor and consultation by the treating physician.\n\nDuring 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.\n\nVenous 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.\n\nAssessment of endothelial function, AI and CAP using SphygmoCor .\n\nPhysician consultation\n\nDuring 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.\n\nSecond visit\n\nThe second visit will only involve blood taking for FLP (5 ml blood) after at least 6 weeks duration of TLC.\n\nThird visit\n\nOnce the FLP results are obtained (in approximately a week), patients will then be seen by the treating physician in the clinic.\n\nPatients who do not achieve the targeted LDL level after TLC and indicated for treatment will be prescribed with statin by the attending physician.\n\nPatients who achieve the targeted LDL level after TLC will continue TLC and will be excluded from the study\n\nFourth visit\n\nThe 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.\n\nFourth visit marks the end of the Study 2. Thereafter, patients will continue their treatment at the KRK.\n\nThe study duration for each subject will be approximately 5 months.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed hypercholesterolemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hypercholesterolaemia: ( LDL \\>4.1 mmol/l)\n2. Age 35 years and above\n3. Agreeable to the treatment with statin if indicated\n\nExclusion Criteria:\n\n1. Pregnancy and breast feeding\n2. Serious medical illness eg kidney failure, liver failure, stroke and malignancy.\n3. Arrythmias\n4. Contraindicated to statin'}, 'identificationModule': {'nctId': 'NCT04512404', 'briefTitle': 'Endothelial Microparticles as Potential Biomarkers of Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Endothelial Microparticles as Potential Biomarkers for Endothelial Dysfunction in Hypercholesterolemia and Its Correlation With Pulse Wave Analysis', 'orgStudyIdInfo': {'id': '1001/PPSP/812211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hypercholesterolemia', 'description': '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.\n\nDuration of treatment: 3-5 months', 'interventionNames': ['Drug: HMG-CoA Reductase Inhibitor']}], 'interventions': [{'name': 'HMG-CoA Reductase Inhibitor', 'type': 'DRUG', 'otherNames': ['statin'], 'armGroupLabels': ['hypercholesterolemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16150', 'city': 'Kubang Kerian', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'Universiti Sains Malaysia', 'geoPoint': {'lat': 6.09123, 'lon': 102.27938}}], 'overallOfficials': [{'name': 'NIk Ibrahim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nik Nor Izah Nik Ibrahim', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}