Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

NCT07476703 | Recruiting DMC

• 1 other identifier: 2024-01556-01
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Arterial Stiffness, Blood Pressure; AORTIC VALVE DISEASES; Mitral Valve Stenosis and/or Insufficiency; Heart Failure; Steatohepatitis; Inflammation Biomarkers; Lipid Profile; Oral Microbiota; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Associated-dysfunction Steatohepatitis (MASH); Pulmonary Disease, Chronic Obstructive (COPD)

Keywords

coronary artery disease; arterial stiffness; MASLD; COPD; inflammation; dyslipidemia; aortic aneurysm; oral microbiota

Outcome Measures

Primary Outcomes (7)

• 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).

  Typically within 1 months of enrollment.

• 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.

  3-8 years

• 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.

  Typically within 1 months of enrollment

• 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.

  Typically within 1 months of enrollment

• Correlation Between Oral Microbiota Composition and Prevalent Coronary Artery Disease

  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).

  Typically within 1 months of enrollment

• Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

  Prevalence of increased estimated hepatic lipid content defined as controlled attenuation parameter (CAP) \>285 dB/m measured by transient elastography (FibroScan).

  Typically within 1 months of enrollment

• Prevalence of Abdominal Aortic Aneurysm

  Prevalence of abdominal aortic aneurysm ≥ 30 mm as determined by abdominal ultrasound imaging.

  Typically within 1 months of enrolment

Secondary Outcomes (28)

• 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

Study Arms (1)

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.

Diagnostic Test: Coronary computer tomography (CCTA); Diagnostic Test: Echocardiograhy and aortic ultrasound; Diagnostic Test: Liver elastography; Diagnostic Test: Arterial stiffness

Interventions

Coronary computer tomography (CCTA) DIAGNOSTIC_TEST

Siemens Naeotom Alpha Photon Counting CT scanner

SCAPIS Stockholm reexamination substudy

Echocardiograhy and aortic ultrasound DIAGNOSTIC_TEST

Echocardiograhy and aortic ultrasound using General Electric Vivid E95

SCAPIS Stockholm reexamination substudy

Liver elastography DIAGNOSTIC_TEST

Liver elastography using Fibroscan ultrasound method.

SCAPIS Stockholm reexamination substudy

Arterial stiffness DIAGNOSTIC_TEST

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

SCAPIS Stockholm reexamination substudy

Eligibility Criteria

• Age: 56 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

Sponsors & Collaborators

• Danderyd Hospital: lead
• Region of Stockholm: collaborator
• Karolinska Institutet: collaborator
• Göteborg University: collaborator

Study Sites (1)

Cardiovascular Research Lab, Dept Cardiology, Danderyd University Hospital

Stockholm, 18288, Sweden

RECRUITING

Related Publications (1)

• Bergstrom G, Berglund G, Blomberg A, Brandberg J, Engstrom G, Engvall J, Eriksson M, de Faire U, Flinck A, Hansson MG, Hedblad B, Hjelmgren O, Janson C, Jernberg T, Johnsson A, Johansson L, Lind L, Lofdahl CG, Melander O, Ostgren CJ, Persson A, Persson M, Sandstrom A, Schmidt C, Soderberg S, Sundstrom J, Toren K, Waldenstrom A, Wedel H, Vikgren J, Fagerberg B, Rosengren A. The Swedish CArdioPulmonary BioImage Study: objectives and design. J Intern Med. 2015 Dec;278(6):645-59. doi: 10.1111/joim.12384. Epub 2015 Jun 19.

  PMID: 26096600 BACKGROUND

Related Links

• List to study website including data platform and published studies

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, saliva.

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease; Heart Failure; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Fatty Liver; Inflammation; Dyslipidemias; Aortic Aneurysm

Interventions

Vascular Stiffness

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Aneurysm; Aortic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Rebecka Hultgren

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Karin Leander

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Paolo Parini

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Daniel Andersson

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Matteo Pedrelli

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Apostolos Bossios

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Georgios Belibasakis

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Tomas Jernberg

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Hannes Hagström

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Magnus Bäck

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Bahira Shahim

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Zhichao Zhou

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Spaak, MD, PhD, Professor

CONTACT

+4681235500; jonas.spaak@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 17, 2026
• Study Start: April 8, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Some data is already available, some core data will be released fall 2026, all data will be available 2032
• Access Criteria: All researchers based in Sweden, or international researchers in collaboration with a researcher based in Sweden, are welcome to apply for data. An approval from the Swedish Ethical Review Board (Etikprövningsmyndigheten) for the research project is obligatory before an application for data from SCAPIS

Locations

SE (1)