Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30154 participants
OBSERVATIONAL
2024-01-15
2030-12-31
Brief Summary
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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.
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Detailed Description
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The five overall objectives of SCAPIS 2 are:
1. To determine characteristics related to the natural progression of atherosclerosis over 8-10 years.
2. To evaluate characteristics related to pathological cardiovascular aging over 8-10 years.
3. To determine characteristics related to the natural progression of lung function over 8-10 years.
4. To determine risk factors associated with the progression of coronary atherosclerosis and the development of impaired lung function or structural changes of the lungs.
5. To compare outcome in individuals who are invited to SCAPIS 2 and those not invited.
SCAPIS 2 will recruit approximately 15,000 subjects randomly selected from the baseline examination (SCAPIS 1) study population approximately 8-10 years after their initial participation. During the SCAPIS 1 random samples of men and women aged 50-64 years were drawn from each recruitment area in the Swedish population registry until approximately 30 000 subjects were included. The final number was 30 154 subjects with an even sex and age distribution. The original recruitment process ensured that the study population in SCAPIS 1 was representative for the Swedish population in general.
An invitation letter with brief information about SCAPIS 2 will be sent to randomly selected individuals by mail, including phone number and e-mail address to the study center. The invitation letter will refer to a study webpage where the subjects can indicate if they are interested in participating in SCAPIS 2 and read the subject information in advance (voluntary). The invitation also includes contact information to the study center to be used if the subject prefers to not use the web page or has questions. Subjects that have moved since their participation in SCAPIS 1 will be invited to the same study center as their baseline examination.
The examinations will be performed during 2-3 days within approximately 2 weeks. Whenever possible, all visits should be performed within a period of 4 weeks. Examinations that are common for all sites include:
* Medical history
* Anthropometry
* Clinical chemistry/hematology: Hb, p-Glucose, HbA1c, s-TG, s- Cholesterol, LDL, HDL, creatinine, detailed leukocyte count)
* Biobank sampling (plasma, serum, whole blood, and urine)
* Spirometry
* CO uptake
* Questionnaires
* Accelerometry (hip)
* Electrocardiogram (ECG)
* Heart rate
* Blood pressure
* Computed tomography (CT)
* Body composition
* Lung tissue
* Coronary artery calcium score (CACS)
* Coronary computed tomography angiography (CCTA)
All subjects will be fasting overnight (at least 8 hours) before the first visit. If a subject has not been fasting overnight, blood sampling should be rescheduled and performed preferably at an extra visit but no later than Visit 2. For subjects with elevated plasma glucose levels, an overnight fasting glucose measurement will be repeated.
Subjects should be instructed to take their regular medication as usual also when fasting. The only medication that should not be taken is medication for diabetes, per oral as well as injections. Subjects with diabetes should be fasting as all other subjects and should bring their medication to take when having breakfast at the clinic. To obtain standardized conditions for the CT examination, subjects are recommended to be fasting for at least 4 hours before intake of a standardized meal. The standardized meal should be consumed 2 hours before the CT scan.
All clinical findings and assessment of risk should be taken care of according to current guidelines and SCAPIS manual.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Lund University
OTHER
Uppsala University
OTHER
Umeå University
OTHER
Linkoeping University
OTHER_GOV
Göteborg University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Tomas Jernberg
Professor
Principal Investigators
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Carl Johan Östgren, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Gothenburg University
Gothenburg, , Sweden
Linköping University
Linköping, , Sweden
Lund University
Lund, , Sweden
Karolinska Institutet
Stockholm, , Sweden
Umeå Universitet
Umeå, , Sweden
Uppsala University
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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website
Other Identifiers
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2024-01
Identifier Type: -
Identifier Source: org_study_id
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