Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06393894 |
Other study ID # |
AAR-0419 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2019 |
Est. completion date |
December 31, 2030 |
Study information
Verified date |
April 2024 |
Source |
Pauls Stradins Clinical University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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.
Exclusion criteria:
- Refusion to participate in the registry
- Men ≥55 years and women ≥65 years
- Coronary artery atherosclerosis < 50% or ≥50% without proven ischaemia and planned
revascularization or no history of coronary artery revascularization
Exclusion criteria for additional genetic analysis and intravascular coronary imaging:
- Diabetes mellitus
- Serum total cholesterol ≥ 7 mmol/l and/or LDL ≥ 5 mmol/l
- Family hypercholesterolemia
- 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)
- ≥20 pack years of smoking
- Malignant or resistant hypertension ≥ 10 years
- Body mass index ≥40 kg/m2
At 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.
In 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.
Patients undergoing repeated coronary angiography or PTCA will undergo intravascular imaging
- near-infrared spectroscopy to determine coronary plaque lipidic tissue content.
Follow-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.