Latvian Early Atherosclerosis Registry

NCT06393894 | Recruiting

• 1 other identifier: AAR-0419
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Atherosclerosis, Coronary

Keywords

Coronary artery disease; Early atherosclerosis; MicroRNA; Near infrared spectroscopy

Outcome Measures

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).

  12 months

Secondary Outcomes (3)

• Major adverse cardiovascular events (MACE)

  12 months

• Intravascular coronary imaging

  12 months

• Target lesion revascularization

  12 months

Interventions

Near infrared spectroscopy DIAGNOSTIC_TEST

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. GENETIC

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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 )
• or more pack years of smoking

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead

Study Sites (1)

Pauls Stradins Clinical University hospital

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Spectroscopy, Near-Infrared; Genetic Testing; Apolipoproteins B

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Clinical Laboratory Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Apolipoproteins; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: May 1, 2024
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)