NCT06679777

Brief Summary

In the Swedish CArdioPulmonary bioImage Study (SCAPIS 1), 30,154 randomly selected men and women, aged 50-64 years, were recruited from six areas in Sweden during 2013-2018. The study population was investigated with CCTA, ultrasound carotids, physical examination, questionnaires, accelerometry, ECG, spirometry, and biochemical markers. The aim was to obtain new information relevant to the identification and treatment of individuals with cardiopulmonary and metabolic diseases and to optimize the possibilities for studying disease mechanisms. In SCAPIS-2, half of the individuals (n≈15,000) included in SCAPIS 1, will be re-examined 2024-2025 with the same investigations as during 2013-2018 except for ultrasound of the carotids.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,154

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2024Dec 2030

Study Start

First participant enrolled

January 15, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 4, 2024

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular death, non-fatal myocardial infarction or stroke.

    Cardiovascular death, non-fatal myocardial infarction or stroke.

    Through study completion, an average of 5 years

Secondary Outcomes (8)

  • Cardiovascular death or non-fatal myocardial infarction

    Through study completion, an average of 5 years

  • Cardiovascular death

    Through study completion, an average of 5 years

  • Myocardial infarction (fatal or non-fatal)

    Through study completion, an average of 5 years

  • Stroke (fatal or non-fatal)

    Through study completion, an average of 5 years

  • Death (all-cause)

    Through study completion, an average of 5 years

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In the Swedish CArdioPulmonary bioImage Study (SCAPIS 1), 30,154 randomly selected men and women, aged 50-64 years, were recruited from six areas in Sweden during 2013-2018. The study population was investigated with CCTA, ultrasound carotids, physical examination, questionnaires, accelerometry, ECG, spirometry, and biochemical markers. The aim was to obtain new information relevant to the identification and treatment of individuals with cardiopulmonary and metabolic diseases and to optimize the possibilities for studying disease mechanisms. In SCAPIS-2, half of the individuals (n≈15,000) included in SCAPIS 1, will be re-examined 2024-2025 with the same investigations as during 2013-2018 except for ultrasound of the carotids.

You may qualify if:

  • \- Participated in SCAPIS 1.

You may not qualify if:

  • Individuals who have withdrawn their informed consent during or after SCAPIS 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gothenburg University

Gothenburg, Sweden

RECRUITING

Linköping University

Linköping, Sweden

RECRUITING

Lund University

Lund, Sweden

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Umeå Universitet

Umeå, Sweden

RECRUITING

Uppsala University

Uppsala, 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: 26096600BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, urine

MeSH Terms

Conditions

Cardiovascular DiseasesLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Carl Johan Östgren, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 7, 2024

Study Start

January 15, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Individual participant data can be shared if approved the Swedish Ethical Review Authority and authority responsible for personal data

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After study completion
Access Criteria
Approval from the Swedish Ethical Review Authority and authority responsible for personal data

Locations