Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 1:53 AM
Study NCT ID:
NCT06393894
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latvian Early Atherosclerosis Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D001055', 'term': 'Apolipoproteins B'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D001053', 'term': 'Apolipoproteins'}, {'id': 'D008074', 'term': 'Lipoproteins'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001059', 'term': 'Apoproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetics', 'timeFrame': '12 months', 'description': 'Correlation between intravascular plaque characteristic data and gene variations in LDLR (low density lipoprotein receptor), APOB (Apolipoprotein B), PCSK9 (proprotein convertase subtilisin/kexin type 9) and LDLRAP1 (Low Density Lipoprotein Receptor Adaptor Protein 1).'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '12 months', 'description': 'Composite of nonfatal myocardial infarction, cardiovascular death, repeat coronary revascularization'}, {'measure': 'Intravascular coronary imaging', 'timeFrame': '12 months', 'description': 'Intravascular plaque characteristic assesment by intravascular diagnostic modalities (intravascular ultrasound and/or near infrared spectroscopy).'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 months', 'description': 'Revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Early atherosclerosis', 'MicroRNA', 'Near infrared spectroscopy'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis, Coronary']}, 'descriptionModule': {'briefSummary': 'Atherosclerosis and its complications are a global problem. There are several widely known and proven risk factors that promotes atherogenesis in the majority of patients. However, significant proportion of apparently healthy and young patients with cardiovascular disease but yet without recognized atherogenesis promoting risk factors can be observed in clinical practice. It highlights the need of new risk markers for early atherosclerosis diagnostics to prevent serious cardiovascular complications in these patients and in population in general. The interest in the negative impact of genetic variance, gene regulation on atherogenesis is growing. Therefore the purpose of this study is to analyze the impact of genetic variance and microRNA expression on early atherosclerosis development in the population of young, apparently healthy patients with coronary atherosclerosis. The primary hypothesis is that the group of patients with premature atherosclerosis have common genetic variations promoting early atherosclerosis development. The secondary hypothesis is that specific circulating microRNA expression (miR-126, miR-145 and miR-155) correlate with plaque lipid core by near infrared spectroscopy (NIRS) analysis.', 'detailedDescription': 'Patients with early atherosclerosis undergoing coronary angiography or percutaneous transluminal coronary angioplasty (PTCA) at Pauls Stradins Clinical University Hospital, Latvia will be included in the early atherosclerosis registry. Patients without explicit atherosclerosis risk factors undergoing coronary angiography or PTCA will undergo near-infrared spectroscopy imaging and blood samples for microRNA expression evaluation and genetic analysis will be obtained.\n\nExclusion criteria:\n\n* Refusion to participate in the registry\n* Men ≥55 years and women ≥65 years\n* Coronary artery atherosclerosis \\< 50% or ≥50% without proven ischaemia and planned revascularization or no history of coronary artery revascularization\n\nExclusion criteria for additional genetic analysis and intravascular coronary imaging:\n\n* Diabetes mellitus\n* Serum total cholesterol ≥ 7 mmol/l and/or LDL ≥ 5 mmol/l\n* Family hypercholesterolemia\n* Positive family history of cardiovascular disease (myocardial infarction, sudden cardiac death or cardiovascular disease of first-degree relatives at a young age - men \\<55 years, women \\<65 years)\n* ≥20 pack years of smoking\n* Malignant or resistant hypertension ≥ 10 years\n* Body mass index ≥40 kg/m2\n\nAt the time of recruitment demographic characteristics, medical and family history, anthropometric parameters, smoking status, history of other risk factors and daily used medications will be recorded and venous blood samples will be obtained.\n\nIn obtained venous blood samples study researchers will evaluate biochemistry analysis which includes high-density and low-density lipoprotein cholesterols, total cholesterol, triglycerides, alanine aminotransaminase, aspartate aminotransferase, bilirubin, creatine kinase, glucose and glycated haemoglobin levels. Genetic analysis will include sequencing of the four major candidate genes for monogenic hypercholesterolemia (LDLR, APOB, PCSK9 and LDLRAP1). microRNA (miR)-126, miR-145 and miR-155 expression will be evaluated in all venous blood samples.\n\nPatients undergoing repeated coronary angiography or PTCA will undergo intravascular imaging - near-infrared spectroscopy to determine coronary plaque lipidic tissue content.\n\nFollow-up phone calls will be performed after 6, 12 and 24 months. In the follow-up study researchers will obtain additional information on study participants including smoking status, daily used medications and anthropometric parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to coronary angiography with or without angioplasty meeting the inclusion criteria and without explicit exclusion criteria will be screened for this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Signed informed consent\n* Early atherosclerosis defined as coronary atherosclerosis in men aged \\<55 years and women \\<65 years\n* Coronary artery atherosclerosis with angiographically proven coronary vessel luminal stenosis ≥ 50% and ischaemia\n* Coronary artery atherosclerosis with planned revascularization\n* History of coronary artery revascularization (PTCA or coronary artery bypass surgery)\n* Coronary vessel suitable for NIRS pullback\n\nExclusion criteria:\n\n* Diabetes\n* Total cholesterol ≥7 mmol/l and/or LDL ≥ 5 mmol/l\n* family hypercholesterolemia\n* positive family history of early cardiovascular disease (myocardial infarction, sudden cardiac death or cardiovascular disease of first degree relatives at young age - men \\<55 years, women \\<65 years)\n* malignant or resistant hypertension ≥ 10 years\n* body mass index ≥40 kg/m 2 )\n* 20 or more pack years of smoking'}, 'identificationModule': {'nctId': 'NCT06393894', 'briefTitle': 'Latvian Early Atherosclerosis Registry', 'organization': {'class': 'OTHER', 'fullName': 'Pauls Stradins Clinical University Hospital'}, 'officialTitle': 'A Prospective Registry to Assess Atherosclerosis Risk Factors and Their Relationship With Coronary Plaque Properties and Genetic Variations in Patients With Early Atherosclerosis of Unclear Origin.', 'orgStudyIdInfo': {'id': 'AAR-0419'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Near infrared spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Near infrared spectroscopy (NIRS) is an intravascular imaging technique. Patients after coronary angiography with or without angioplasty will undergo NIRS if deemed suitable by the interventionalist. NIRS has a high sensitivity and specificity for lipid core plaque detection.'}, {'name': 'Genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 mutations and niR-126, -145 and -155 expression.', 'type': 'GENETIC', 'description': 'Patients without explicit atherosclerosis risk factors and known genetic disorders will undergo genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 genes in order to evaluate the presence of gene variations as a cause for early atherosclerosis. MiRNA-126, -145 and -155 expression in patients serum samples will be evaluated and correlated with plaque lipid core in near infrared spectroscopy (NIRS) imaging.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'contacts': [{'name': 'Karlis Trusinskis, Prof', 'role': 'CONTACT', 'email': 'cardio@inbox.lv', 'phone': '+371 6709 5343'}], 'facility': 'Pauls Stradins Clinical University hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pauls Stradins Clinical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karlis Trusinskis', 'investigatorAffiliation': 'Pauls Stradins Clinical University Hospital'}}}}