Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393894
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2020-09-15
Brief Title:
Latvian Early Atherosclerosis Registry
Sponsor:
Pauls Stradins Clinical University Hospital
Organization:
Pauls Stradins Clinical University Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 mmoll andor LDL 5 mmoll
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 kgm2
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
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 mmoll andor LDL 5 mmoll
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 kgm2
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None