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Идёт набор NCT07476703

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

Наблюдательное Coronary Artery Disease Arterial Stiffness, Blood Pressure AORTIC VALVE DISEASES Mitral Valve Stenosis and/or Insufficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Coronary computer tomography (CCTA), Echocardiograhy and aortic ultrasound, Liver elastography, Arterial stiffness.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, Arterial Stiffness, Blood Pressure, AORTIC VALVE DISEASES, Mitral Valve Stenosis and/or Insufficiency. Базовые параметры: 56 лет — 74 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Expanded Studies of Risk Factors for Pulmonary-, Liver-, and Cardiovascular Disease in the SCAPIS 2 Stockholm Reexamination

Обзор

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.

Подробное описание

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:

EXTENDED SAMPLING: Saliva and Blood Samples with Blood Cell Isolation Additional blood samples will be collected to isolate blood cells for detailed immune system profiling, red blood cell function nd for lipid profiles and inflammatory markers. Saliva samples will be analyzed for inflammatory markers and microbial composition.

EXTENDED QUESTIONNAIRES: Dyspnea, Sleep, Respiratory Infections, and Dental Health Participants will complete detailed questionnaires covering recent food, drink, and medication intake; oral hygiene; breathing and lung function; sleep quality and daytime somnolence; and history of respiratory infections, including COVID-19.

EXTENDED IMAGING AND PHYSIOLOGICAL MEASUREMENTS: These investigations will be conducted during a separate visit, coordinated with the main study, and take approximately one hour.

1. Cardiac Ultrasound and Abdominal Aortic Measurements: cardiac structure and function, as well as the diameter of major arteries (e.g., the thoracic and abdominal aorta). 2. Liver Elastography: An ultrasound-based technique used to assess liver stiffness and fat content. 3. Vascular Stiffness: Blood pressure cuff-based pulse wave analysis with automated stiffness calculation. Photoplethysmography (PPG) using skin-mounted sensors (commonly used for oxygen saturation monitoring, in cuffless blood pressure monitors and wearables). Single-lead ECG via adhesive electrodes. 4. Valvular and Vascular Calcification: In the main SCAPIS study, CT imaging of the heart and large vessels will be performed. In SCAPIS 2, images will be re-analyzed using algorithms that quantify calcium deposits in heart valves.

RESEARCH QUESTIONS

Blood and blood cell analyses will be conducted to assess immune activation, lipids and lipid mediators, and immune cell phenotypes. These analyses aim to distinguish chronic from self-limiting cardiovascular inflammation and to detect prevalent, incident, and subclinical cardiovascular disease (CVD) for improved risk assessment.

Saliva biomarkers, with a focus on inflammation and oral microbiota, will be studied to explore links between oral health, respiratory health, systemic inflammation, and comorbidities.

Survey data on sleep, breathing, respiratory infections, and oral health will be used to investigate associations with liver, lung, and cardiovascular diseases, including their risk factors and prognosis.

The prevalence of liver steatosis and fibrosis in the general population wil be examined, along with their associations with CVD and heart failure. It will also be assess whether SCAPIS data can predict liver stiffness.

Risk factors for cardiac dysfunction and valvular disease, as well as progression to heart failure will be analyzed. CT-based calcium scoring in the aorta and valves will be studied for associations to valve disease, heart failure, intervention timing, and progression of aortic dilation between SCAPIS 1 and 2.

Aortic aneurysm prevalence and risk factors will be evaluated, including associations with SCAPIS variables and incident cardiovascular disease. Infrarenal aortic diameter is also used as a subclinical marker of aortic aneurysm.

New techniques using photoplethysmography (PPG) for arterial stiffness and pulse characteristics will be studied in relation to coronary artery disease, cardiac structure and function, valve disease, liver stiffness, biomarkers, and blood pressure.

Finally, SCAPIS and SCAPIS 2 data will be integrated including substudy results for comprehensive risk assessment of clinical and subclinical CVD and to guide prevention strategies.

Вмешательства

  • Диагностический тест Coronary computer tomography (CCTA)
    Siemens Naeotom Alpha Photon Counting CT scanner
  • Диагностический тест Echocardiograhy and aortic ultrasound
    Echocardiograhy and aortic ultrasound using General Electric Vivid E95
  • Диагностический тест Liver elastography
    Liver elastography using Fibroscan ultrasound method.
  • Диагностический тест Arterial stiffness
    Arterial stiffness using Arteriograph, Tensiomed, Hungary and Photoplethysmography and ECG by ADInstrument

Первичные конечные точки

  • Diagnostic Performance of Machine Learning Analysis of Finger Photoplethysmography for Detection of Coronary Artery Disease (CAD-RADS ≥2) [Срок оценки: Typically within 1 months of enrollment.]
  • Long-Term Incident Major Adverse Renal and Cardiovascular Events (MARCE) [Срок оценки: 3-8 years]
  • Immune Activation Biomarkers and Prevalent Atherosclerotic Cardiovascular Disease [Срок оценки: Typically within 1 months of enrollment]
  • Lipid Mediator Profiles and Prevalent Atherosclerotic Cardiovascular Disease [Срок оценки: Typically within 1 months of enrollment]
  • Correlation Between Oral Microbiota Composition and Prevalent Coronary Artery Disease [Срок оценки: Typically within 1 months of enrollment]
  • Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) [Срок оценки: Typically within 1 months of enrollment]
  • Prevalence of Abdominal Aortic Aneurysm [Срок оценки: Typically within 1 months of enrolment]
Вторичные конечные точки (12)
  • Multimodal artificial intelligence (AI) model for prediction of coronary artery disease (CAD) [Срок оценки: Typically within 1 month of enrollment]
  • Photoplethysmograpy (PPG) to predict prevalent coronary artery disease [Срок оценки: Typically within 3 months of enrollment]
  • Incremental Predictive Value of Photoplethysmography Beyond Traditional Cardiovascular Risk Models [Срок оценки: Typically within 1 month of enrollment]
  • Lipid Mediator Profiles and Coronary Artery Disease Severity [Срок оценки: SCAPIS baseline and SCAPIS2 re-examination (8-10 years).]
  • Arterial stiffness [Срок оценки: Typically within 3 months of enrollment]
  • Prevalence of valvular disease and aortic calcification [Срок оценки: Typically within 1 month of enrollment]
  • Machine learning to predict aortic and mitral valve disease [Срок оценки: Typically within 1 month of enrollment]
  • Agreement between CCTA and cardiac doppler ultrasound [Срок оценки: Typically within 3 months of enrollment]
  • Photoplethysmography (PPG) and aortic valve disease [Срок оценки: Typically within 3 months of enrollment]
  • Prevalence and predictors of thoracic aortic dilatation [Срок оценки: Typically within 3 months of enrollment]
  • Left ventricular mass and hypertension [Срок оценки: Typically within 3 months of enrollment]
  • Left ventricular and left atrial strain [Срок оценки: Typically within 3 months of enrollment]

Критерии участия

Inclusion Criteria: Subjects already included in the main / general SCAPIS reexamination study in Stockholm.

Exclusion Criteria: Inability to provide consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Cardiovascular Research Lab, Dept Cardiology, Danderyd University Hospital — Stockholm

Публикации

  • 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 CArdioPulmon PMID 26096600

Идентификаторы

NCT: NCT07476703 · 2024-01556-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗