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Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

ConditionsCoronary Artery DiseaseArterial Stiffness, Blood PressureAORTIC VALVE DISEASESMitral Valve Stenosis and/or InsufficiencyHeart FailurePulmonary Disease, Chronic Obstructive (COPD)SteatohepatitisInflammation BiomarkersLipid ProfileOral MicrobiotaMASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Associated-dysfunction Steatohepatitis (MASH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age56-74
SponsorDanderyd Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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. 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coronary computer tomography (CCTA)

    Diagnostic test

    Siemens Naeotom Alpha Photon Counting CT scanner

  • Echocardiograhy and aortic ultrasound

    Diagnostic test

    Echocardiograhy and aortic ultrasound using General Electric Vivid E95

  • Liver elastography

    Diagnostic test

    Liver elastography using Fibroscan ultrasound method.

  • Arterial stiffness

    Diagnostic test

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

Treatment groups

1,400 Participants
are divided into 1 treatment group
Group A: SCAPIS Stockholm reexamination substudy4 interventions

Trial outcomes

Primary outcomes

1

Diagnostic Performance of Machine Learning Analysis of Finger Photoplethysmography for Detection of Coronary Artery Disease (CAD-RADS ≥2)

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).

Time frame
Typically within 1 months of enrollment.
2

Long-Term Incident Major Adverse Renal and Cardiovascular Events (MARCE)

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.

Time frame
3-8 years
3

Immune Activation Biomarkers and Prevalent Atherosclerotic Cardiovascular Disease

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.

Time frame
Typically within 1 months of enrollment
4

Lipid Mediator Profiles and Prevalent Atherosclerotic Cardiovascular Disease

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.

Time frame
Typically within 1 months of enrollment

Secondary outcomes

1

Multimodal artificial intelligence (AI) model for prediction of coronary artery disease (CAD)

Machine learning methods will be applied to identify the most informative predictors of CAD. Multimodal data, including ECG-derived features, lipid mediator measurements, inflammatory biomarkers, ultrasound variables, and oral microbiota profiles, will be used to develop and evaluate a prediction model for CAD, defined as CAD-RADS ≥2. Cross-validation will be used to reduce the risk of overfitting. Model performance will be evaluated using measures of discrimination and calibration. Clinical decision-curve analysis will be used to assess the clinical utility of the model by estimating net benefit across relevant decision thresholds and comparing model-guided decisions with current clinical practice (the pooled cohort equation).

Time frame
Typically within 1 month of enrollment
2

Photoplethysmograpy (PPG) to predict prevalent coronary artery disease

Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥2 and SIS and CAC-score when adding PPG features to age and sex.

Time frame
Typically within 3 months of enrollment
3

Incremental Predictive Value of Photoplethysmography Beyond Traditional Cardiovascular Risk Models

Improvement in AUC-ROC for predicting CAD-RADS category, segment involvement score (SIS), and coronary artery calcium (CAC) score when adding machine learning-derived PPG features to traditional cardiovascular risk factors including the Pooled Cohort Equation.

Time frame
Typically within 1 month of enrollment
4

Lipid Mediator Profiles and Coronary Artery Disease Severity

Association between circulating lipid mediator profiles including plasma remnant cholesterol and coronary artery disease severity assessed by CCTA using CAD-RADS, SIS and CAC-score.

Time frame
SCAPIS baseline and SCAPIS2 re-examination (8-10 years).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danderyd Hospital

Lead sponsor

Region Stockholm

Collaborator

Karolinska Institutet

Collaborator

Göteborg University

Collaborator

Source ClinicalTrials.gov
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