Clinical trial

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.

Name

AAR-0419

Description

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.

Trial arms

Trial start

2019-04-01

Estimated PCD

2030-12-31

Trial end

2030-12-31

Status

Recruiting

Treatment

Near infrared spectroscopy

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.

Genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 mutations and niR-126, -145 and -155 expression.

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.

Size

100

Primary endpoint

Genetics

12 months

Eligibility criteria

Inclusion criteria: * 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 * History of coronary artery revascularization (PTCA or coronary artery bypass surgery) * Coronary vessel suitable for NIRS pullback Exclusion criteria: * 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) * malignant or resistant hypertension ≥ 10 years * body mass index ≥40 kg/m 2 ) * 20 or more pack years of smoking

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '24 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-05-01

1 organization

1 product

3 indications

Organization

Pauls Stradins Clinical University Hospital

Product

Genetic testing for LDLR, APOB, PCSK9, and LDLRAP1 mutations and miR-126, -145, and -155 expression

Indication

Coronary Artery Disease

Indication

Atherosclerosis

Indication

Coronary