Coronary Artery DiseaseNCT06393894
Latvian Early Atherosclerosis Registry
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Coronary
- What is being tested?
- Near infrared spectroscopy and Genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 mutations and niR-126, -145 and -155 expression.
- How many people
- 100 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Apr 2019to 31 Dec 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University hospital
Riga
Karlis Trusinskis, Prof, +371 6709 5343, cardio@inbox.lv
About this study
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.
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.
Read the 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 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.
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary
- Being tested
- Near infrared spectroscopy, Genetic testing for LDLR, APOB, PCSK9 and LDLRAP1 mutations and niR-126, -145 and -155 expression.
- Keywords
- Coronary artery disease, Early atherosclerosis, MicroRNA, Near infrared spectroscopy
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
Major adverse cardiovascular events (MACE)
Composite of nonfatal myocardial infarction, cardiovascular death, repeat coronary revascularization
Measured: 12 months
Intravascular coronary imaging
Intravascular plaque characteristic assesment by intravascular diagnostic modalities (intravascular ultrasound and/or near infrared spectroscopy).
Measured: 12 months
Target lesion revascularization
Revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Apr 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karlis Trusinskis, Pauls Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393894
- Sponsor's protocol ID
- AAR-0419
- Status last verified
- Apr 2024
- First submitted
- 15 Sep 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06393894
- Acronym / sponsor ID
- AAR-0419
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary
- Keywords
- Coronary artery disease, Early atherosclerosis, MicroRNA, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopyNear 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. | Diagnostic test | – |
| 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. | Genetic | – |
Primary outcome
Genetics
Time frame: 12 months
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).
3 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 12 months
Intravascular coronary imaging
Time frame: 12 months
Target lesion revascularization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetics (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.