Prospective Cohort Study of Patients Undergoing Coronary Angiography in Vorarlberg, Austria (KS3)
This prospective observational cohort study investigates cardiovascular outcomes and associated risk factors in patients undergoing coronary angiography for suspected or established coronary artery disease at Feldkirch Regional Hospital in Vorarlberg, Austria.
The study aims to identify clinical, metabolic, laboratory, and lifestyle factors associated with coronary artery disease and subsequent cardiovascular events. Baseline assessments include clinical characteristics, cardiovascular risk factors, laboratory measurements, and lifestyle-related information.
The primary outcomes are all-cause mortality and cardiovascular events. Follow-up assessments are conducted approximately every two years through telephone interviews and review of available clinical records and databases. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records. Long-term follow-up is planned to evaluate cardiovascular outcomes and changes in risk factors over time.
The study aims to enroll approximately 2,000 participants, with recruitment ongoing.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Coronary artery disease remains a major cause of morbidity and mortality despite advances in cardiovascular prevention, diagnosis, and treatment. Patients undergoing coronary angiography frequently present with cardiovascular risk factors and comorbidities, including diabetes mellitus, dyslipidemia, hypertension, and chronic kidney disease. Changes in therapeutic strategies highlight the need for contemporary prospective cohort data to improve cardiovascular risk assessment.
This study is designed to investigate the associations between clinical, metabolic, laboratory, and lifestyle-related characteristics and subsequent cardiovascular outcomes in patients undergoing clinically indicated coronary angiography for suspected or established stable coronary artery disease.
The study objectives include identifying risk factors associated with cardiovascular events and angiographically detectable coronary artery disease, evaluating longitudinal changes in anthropometric, lifestyle-related, and laboratory parameters, and investigating the relationships between cardiovascular and metabolic risk factors.
At baseline, participants undergo comprehensive clinical and laboratory assessments, including evaluation of cardiovascular risk factors, comorbidities, medication use, and lifestyle-related characteristics. Biological samples are collected for laboratory analyses and stored for further investigations.
Participants are followed approximately every two years through telephone interviews and review of available clinical records and databases to document nonfatal cardiovascular events and changes in relevant clinical characteristics. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records.
The primary outcomes are all-cause mortality and cardiovascular events. Long-term follow-up is planned to investigate cardiovascular outcomes and their associations with baseline characteristics and risk factors over time.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Vorarlberg
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Feldkirch, Vorarlberg, Австрия, 6800
- Рекрутинг
- LKH Feldkirch
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Контакт:
- Doris Hanfstingl-Sinz, DGKP
- Номер телефона: +43 5522 3036905
- Электронная почта: doris.hanfstingl-sinz@vlkh.at
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Контакт:
- Cornelia Malin, PhD
- Номер телефона: +43 5522 3036902
- Электронная почта: vivit@lkhf.at
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Главный следователь:
- Alexander Vonbank, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The study population consists of consecutive adult patients (≥18 years) undergoing clinically indicated coronary angiography for the evaluation of suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria. Eligible patients are prospectively enrolled after providing written informed consent. Patients presenting with acute coronary syndrome are excluded. The planned study population comprises approximately 2,000 participants.
Описание
Inclusion Criteria:
- Age ≥18 years.
- Clinically indicated coronary angiography for the evaluation of suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria.
- Written informed consent to participate in the study after receiving comprehensive information about the study.
Exclusion Criteria:
- Age under 18 years.
- Pregnancy.
- Individuals detained by order of a judicial or administrative authority.
- Known current alcohol or illicit drug abuse that, in the investigator's judgment, may compromise participant safety or compliance.
- Close relationship with the study site, including relatives of investigators or individuals in a dependent relationship with study personnel.
- Inability to understand and sign the informed consent form.
- Acute coronary syndrome.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Patients Undergoing Coronary Angiography
Adult patients undergoing clinically indicated coronary angiography for suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria. Baseline clinical and laboratory assessments are performed at enrollment. Participants are prospectively followed to evaluate all-cause mortality, cardiovascular events, and associated risk factors. Follow-up data are collected through telephone interviews and queries of relevant clinical and administrative databases. |
Coronary angiography performed as part of routine clinical care for the evaluation of suspected or established stable coronary artery disease. The procedure is clinically indicated and is not assigned by the study protocol. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of Cardiovascular Events
Временное ограничение: 2 years after baseline coronary angiography
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Occurrence of cardiovascular events within two years after baseline coronary angiography. Events are ascertained during follow-up and verified using available medical records. |
2 years after baseline coronary angiography
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All-Cause Mortality
Временное ограничение: 2 years after baseline coronary angiography
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All-cause mortality, defined as death from any cause within two years after baseline coronary angiography. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records. |
2 years after baseline coronary angiography
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Соавторы и исследователи
Следователи
- Директор по исследованиям: Christoph Saely, MD, VIVIT
- Учебный стул: Heinz Drexel, MD, VIVIT
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- VIVIT-KS3-2021
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data will not be made publicly available. Study data are pseudonymized and managed in accordance with applicable data protection regulations. No general sharing of individual participant data with external researchers is currently planned.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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