Latvian Early Atherosclerosis Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPauls Stradins Clinical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Early atherosclerosis defined as coronary atherosclerosis in men aged <55 years and women <65 years
Coronary artery atherosclerosis with angiographically proven coronary vessel luminal stenosis ≥ 50% and ischaemia
Coronary artery atherosclerosis with planned revascularization
Disqualifiers
Diabetes
Total cholesterol ≥7 mmol/l and/or LDL ≥ 5 mmol/l
family hypercholesterolemia
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)
Trial population
Patients referred to coronary angiography with or without angioplasty meeting the inclusion criteria and without explicit exclusion criteria will be screened for this registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Near infrared spectroscopy
Diagnostic testNear 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.
Genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 mutations and niR-126, -145 and -155 expression.
GeneticPatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Genetics
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).
Time frame
12 monthsSecondary outcomes
1
Major adverse cardiovascular events (MACE)
Composite of nonfatal myocardial infarction, cardiovascular death, repeat coronary revascularization
Time frame
12 months2
Intravascular coronary imaging
Intravascular plaque characteristic assesment by intravascular diagnostic modalities (intravascular ultrasound and/or near infrared spectroscopy).
Time frame
12 months3
Target lesion revascularization
Revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov