RECRUITINGN/A

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

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.

Sponsor

Danderyd Hospital

Enrollment

1,400 participants

Sites

1 locations

Start Date

April 2024

Completion

March 2026

Coronary Artery DiseaseArterial Stiffness, Blood PressureAORTIC VALVE DISEASESMitral Valve Stenosis and/or InsufficiencyHeart Failure

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

1,400

participants

Sites

locations

Duration

2.3 years

total trial span

Rate

pts/month needed

Apr 2024Month 26 of 28Mar 2026

93% of trial timeline elapsed2 months to primary endpoint

At 1 sites, each site needs to enroll approximately 50.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The Swedish CArdioPulmonary BioImage Study: objectives and design.

Bergström G, Berglund G, Blomberg A et al.Journal of internal medicine2016

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGN/A

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

Sponsor

Danderyd Hospital

Enrollment

1,400 participants

Sites

1 locations

Start Date

April 2024

Completion

March 2026

Coronary Artery DiseaseArterial Stiffness, Blood PressureAORTIC VALVE DISEASESMitral Valve Stenosis and/or InsufficiencyHeart Failure

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

1,400

participants

Sites

locations

Duration

2.3 years

total trial span

Rate

pts/month needed

Apr 2024Month 26 of 28Mar 2026

93% of trial timeline elapsed2 months to primary endpoint

At 1 sites, each site needs to enroll approximately 50.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The Swedish CArdioPulmonary BioImage Study: objectives and design.

Bergström G, Berglund G, Blomberg A et al.Journal of internal medicine2016

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

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.

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (1)