Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

Condition(s) studied

Investigational drug(s) / intervention(s)

Coronary computer tomography (CCTA): Siemens Naeotom Alpha Photon Counting CT scanner

Echocardiograhy and aortic ultrasound: Echocardiograhy and aortic ultrasound using General Electric Vivid E95

Liver elastography: Liver elastography using Fibroscan ultrasound method.

Arterial stiffness: Arterial stiffness using Arteriograph, Tensiomed, Hungary and Photoplethysmography and ECG by ADInstrument

Study summary

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.

Eligibility

Primary outcome measure(s)

• Diagnostic Performance of Machine Learning Analysis of Finger Photoplethysmography for Detection of Coronary Artery Disease (CAD-RADS ≥2) — 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) — 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 — 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 — 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.
• Correlation Between Oral Microbiota Composition and Prevalent Coronary Artery Disease — 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).
• Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) — 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 — Typically within 1 months of enrolment
  Prevalence of abdominal aortic aneurysm ≥ 30 mm as determined by abdominal ultrasound imaging.

Trial sites (1)

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