Expanded Studies of Risk Factors for Pulmonary-, Liver-, and Cardiovascular Disease in the SCAPIS 2 Stockholm Reexamination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Correlation Between Oral Microbiota Composition and Prevalent Coronary Artery Disease
研究概览
简要总结
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018. The study is a collaborative effort among six university hospitals across Sweden. A follow-up study, SCAPIS 2, is conducted for half of the original participants. In Stockholm, 2,500 individuals will be re-examined at Danderyd University Hospital and Karolinska Institutet.
SCAPIS 2 includes a core set of examinations involving blood sampling, questionnaires, and imaging. In addition to these, complementary local investigations are conducted to enable more detailed research questions. This protocol describes the additional studies conducted in the Stockholm cohort. All complementary assessments aim to identify risk factors for current and future lung, liver, and cardiovascular diseases.:
EXTENDED SAMPLING: Saliva and Blood Samples with Blood Cell Isolation. EXTENDED QUESTIONNAIRES: Dyspnea, Sleep, Respiratory Infections, and Dental Health.
EXTENDED IMAGING AND PHYSIOLOGICAL MEASUREMENTS Cardiac Ultrasound and Abdominal Aortic Measurements. Liver Elastography. Vascular Stiffness by cuff-based pulse wave analysis and Photoplethysmography (PPG). Valvular and Vascular Calcification by CT imaging.
详细描述
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018. The study is a collaborative effort among six university hospitals across Sweden. A follow-up study, SCAPIS 2, is conducted for half of the original participants. In Stockholm, 2,500 individuals will be re-examined at Danderyd University Hospital and Karolinska Institutet.
SCAPIS 2 includes a core set of examinations involving blood sampling, questionnaires, and imaging. In addition to these, complementary local investigations are conducted to enable more detailed research questions. This protocol describes the additional studies conducted in the Stockholm cohort:
EXTENDED SAMPLING: Saliva and Blood Samples with Blood Cell Isolation Additional blood samples will be collected to isolate blood cells for detailed immune system profiling, red blood cell function nd for lipid profiles and inflammatory markers. Saliva samples will be analyzed for inflammatory markers and microbial composition.
EXTENDED QUESTIONNAIRES: Dyspnea, Sleep, Respiratory Infections, and Dental Health Participants will complete detailed questionnaires covering recent food, drink, and medication intake; oral hygiene; breathing and lung function; sleep quality and daytime somnolence; and history of respiratory infections, including COVID-19.
EXTENDED IMAGING AND PHYSIOLOGICAL MEASUREMENTS: These investigations will be conducted during a separate visit, coordinated with the main study, and take approximately one hour.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 56 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects already included in the main / general SCAPIS reexamination study in Stockholm.
排除标准
- •Inability to provide consent.
研究组 & 干预措施
SCAPIS Stockholm reexamination substudy
In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS Reexamination is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd University Hospital site) that corresponds to 2500 adults that are now between 6-10 years older than in the first SCAPIS study. The present study is a prospective, observational substudy of a convenient sample from the SCAPIS reexamination in Stockholm.
干预措施: Coronary computer tomography (CCTA) (Diagnostic Test)
SCAPIS Stockholm reexamination substudy
In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS Reexamination is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd University Hospital site) that corresponds to 2500 adults that are now between 6-10 years older than in the first SCAPIS study. The present study is a prospective, observational substudy of a convenient sample from the SCAPIS reexamination in Stockholm.
干预措施: Echocardiograhy and aortic ultrasound (Diagnostic Test)
SCAPIS Stockholm reexamination substudy
In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS Reexamination is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd University Hospital site) that corresponds to 2500 adults that are now between 6-10 years older than in the first SCAPIS study. The present study is a prospective, observational substudy of a convenient sample from the SCAPIS reexamination in Stockholm.
干预措施: Liver elastography (Diagnostic Test)
SCAPIS Stockholm reexamination substudy
In SCAPIS (2014 -2018) 30.000 randomly selected adults between the ages of 50 - 64 were included. SCAPIS Reexamination is the re-assessment study of half of the original study cohort. In Stockholm (Danderyd University Hospital site) that corresponds to 2500 adults that are now between 6-10 years older than in the first SCAPIS study. The present study is a prospective, observational substudy of a convenient sample from the SCAPIS reexamination in Stockholm.
干预措施: Arterial stiffness (Diagnostic Test)
结局指标
主要结局
Correlation Between Oral Microbiota Composition and Prevalent Coronary Artery Disease
时间窗: Typically within 1 months of enrollment
Correlation between oral viral, fungal, and bacterial microbiota composition and degree of coronary artery disease as assessed by CCTA (CAD-RADS, SIS and CAC-score).
Diagnostic Performance of Machine Learning Analysis of Finger Photoplethysmography for Detection of Coronary Artery Disease (CAD-RADS ≥2)
时间窗: Typically within 1 months of enrollment.
Area under the receiver operating characteristic curve (AUC-ROC) for prediction of CAD-RADS ≥2 using machine learning analysis of finger photoplethysmography. CAD-RADS 2.0 classification is based on coronary computed tomography angiography (CCTA), where stenosis severity is graded 0-5, atherosclerotic burden is quantified using segment involvement score (SIS) and calcification using Agatston Units (CAC-score).
Long-Term Incident Major Adverse Renal and Cardiovascular Events (MARCE)
时间窗: 3-8 years
Incidence of major adverse renal and cardiovascular events during follow-up. Associations will be evaluated with baseline immune mediators, lipid mediators, oral microbiota composition, vascular stiffness, steatohepatitis, and fibrosis measures.
Immune Activation Biomarkers and Prevalent Atherosclerotic Cardiovascular Disease
时间窗: Typically within 1 months of enrollment
Correlation between circulating biomarkers of immune activation and the degree of calcification and/or atherosclerosis at examined cardiovascular sites. Atherosclerosis and calcification are assessed by CCTA and/or ultrasound imaging and/or prior diagnosis of atherosclerotic cardiovascular disease. Immune profiling distinguishes resolving and non-resolving inflammatory phenotypes.
Lipid Mediator Profiles and Prevalent Atherosclerotic Cardiovascular Disease
时间窗: Typically within 1 months of enrollment
Correlation between circulating lipid mediator profiles and degree of calcification and/or atherosclerosis at examined cardiovascular sites. Lipid profiling characterizes inflammatory phenotypes and evaluates associations with prior diagnosis of atherosclerotic cardiovascular disease, calcification, and/or imaging-defined atherosclerosis assessed by CCTA and/or ultrasound.
Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
时间窗: Typically within 1 months of enrollment
Prevalence of increased estimated hepatic lipid content defined as controlled attenuation parameter (CAP) \>285 dB/m measured by transient elastography (FibroScan).
Prevalence of Abdominal Aortic Aneurysm
时间窗: Typically within 1 months of enrolment
Prevalence of abdominal aortic aneurysm ≥ 30 mm as determined by abdominal ultrasound imaging.
次要结局
- Multimodal artificial intelligence (AI) model for prediction of coronary artery disease (CAD)(Typically within 1 month of enrollment)
- Photoplethysmograpy (PPG) to predict prevalent coronary artery disease(Typically within 3 months of enrollment)
- Incremental Predictive Value of Photoplethysmography Beyond Traditional Cardiovascular Risk Models(Typically within 1 month of enrollment)
- Lipid Mediator Profiles and Coronary Artery Disease Severity(SCAPIS baseline and SCAPIS2 re-examination (8-10 years).)
- Arterial stiffness(Typically within 3 months of enrollment)
- Prevalence of valvular disease and aortic calcification(Typically within 1 month of enrollment)
- Machine learning to predict aortic and mitral valve disease(Typically within 1 month of enrollment)
- Agreement between CCTA and cardiac doppler ultrasound(Typically within 3 months of enrollment)
- Photoplethysmography (PPG) and aortic valve disease(Typically within 3 months of enrollment)
- Prevalence and predictors of thoracic aortic dilatation(Typically within 3 months of enrollment)
- Left ventricular mass and hypertension(Typically within 3 months of enrollment)
- Left ventricular and left atrial strain(Typically within 3 months of enrollment)
- Correlation between arterial stiffness and left ventricular hypertrophy(Typically within 3 months of enrollment)
- Photoplethysmography and cardiac function(Typically within 3 months of enrollment)
- Prevalence of hepatic fibrosis(Typically within 3 months of enrollment)
- Predictors of hepatic disease(Typically within 3 months of enrollment)
- Prevalence of abdominal aortic subaneurysm(Typically within 3 months of enrollment)
- Predictors and factors associated with infrarenal aortic diameter(Typically within 3 months of enrollment)
- Association of oral dysbiosis and proteome deregulation with respiratory health, lung imaging, lung function and respiratory symptoms.(Typically, within 12 months of enrolment)
- Prevalence of oral dysbiosis and proteome deregulation, and their associations with airway diseases such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, and lung parenchymal diseases.(Typically, within 12 months of enrolment)
- Association of oral dysbiosis and proteome deregulation with respiratory health and systemic inflammation(Typically, within 12 months of enrolment)
- Association of oral dysbiosis and proteome deregulation with respiratory health and comorbidities(Typically, within 12 months of enrolment)
- Targeted plasma inflammatory markers to predict prevalent coronary artery disease(Typically within 3 months of enrollment)
- Gene expression profiling in peripheral blood mononuclear cells (PBMC) and remnant cholesterol(Typically within 3 months of enrollment)
- Additional value of Plasma Apolipoproteins to Predict Prevalent Coronary Artery Disease(Typically within 2 months of enrollment)
- Prevalence of lipid composition(Typically within 3 months of enrollment)
- Erythrocyte Dysfunction and Coronary Artery Disease(Typically within 3 months of enrollment)
- Machine learning of photoplethysmography (PPG) to predict mitral valve disease(Typically within 3 months of enrolment)