Исследование CoPenHagen PREeClampsia и СЕРДЕЧНО-СОСУДИСТЫХ ЗАБОЛЕВАНИЙ (CPH-PRECIOUS)
Сердечно-сосудистые заболевания после преэклампсии
Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world.
Objective:
The purpose of this study is to investigate 1) the prevalence of CVD after PE, 2) which women have the highest risk of developing CVD, 3) when early stages of CVD can be detected in women with previous PE and 4) how CVD progress over time.
Methods:
1000 women with previous PE between the age of 35-55 years will be invited to participate in a follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan and questionnaires. Coronary atherosclerosis will be evaluated using CT imaging.The women will be compared with women with a formerly uncomplicated pregnancy,
Summary:
The study will provide new important information to guide future clinical follow-up, and potentially prevent disease and early death in a large group of women with a history of PE.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world. Despite this, solid and uniform guidelines regarding follow-up after a pregnancy complicated by PE are lacking. Little is known about the time-course of the development of CVD and how early stages can be identified in women with previous PE. The link between PE and CVD is well established. However, no large clinical study using cardiac CT-scans exists. Moreover, the study will focus on the time-perspective of the development of CVD in relation to index pregnancy, and this knowledge may prove to be essential to establish solid clinical guidelines addressing timely prevention and treatment.
The purpose of this study is to investigate
- The prevalence of CVD after PE,
- Which women have the highest risk of developing CVD
- When early stages of CVD can be detected in women with previous PE
- How CVD progress over time.
Thus, we hope to identify a window of opportunity where screening and preventive measures may be relevant and potentially beneficial to these women.
A total of 1000 women with previous PE (aged 35-55 years) will be invited to participate in a clinical follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan (identifying coronary atherosclerotic changes) and questionnaires. These women will be compared to age-matched women, without previous preeclampsia investigated in the Copenhagen General Population Study with an identical CT protocol.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Copenhagen, Дания, 2100
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
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Copenhagen, Дания, 2100
- Department of Obstetrics, Rigshospitalet
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Herlev, Дания, 2730
- The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
A total of 1000 women with previous preeclampsia will be invited to participate in a post-pregnancy clinical cardiovascular CT follow-up study. These women will be compared to age-matched women, without previous preeclampsia investigated in the Copenhagen General Population Study with an identical CT protocol.
Описание
Inclusion Criteria
- Women with a history of preeclampsia
Exclusion Criteria
- Severe physical or mental disabilities
- Lack of ability to speak and/or understand Danish language
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: CASE_CONTROL
- Временные перспективы: PROSPECTIVE
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Coronary atherosclerosis
Временное ограничение: Assessed within 30 days of study inclusion
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Presensence of coronary plaque as defined by Cardiac CT |
Assessed within 30 days of study inclusion
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Presence of left bundle branch block
Временное ограничение: Assessed within 30 days of study inclusion
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Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
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|
Presence of atrial fibrillation
Временное ограничение: Assessed within 30 days of study inclusion
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Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
|
|
Presence of T-wave inversion
Временное ограничение: Assessed within 30 days of study inclusion
|
Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
|
|
Presence of left ventricular hypertrophy
Временное ограничение: Assessed within 30 days of study inclusion
|
Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
|
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Arterial hypertension
Временное ограничение: Assessed within 30 days of study inclusion
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Presence of elevated blood pressure |
Assessed within 30 days of study inclusion
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Dyspnoe
Временное ограничение: Assessed within 30 days of study inclusion
|
New York Heart Association class |
Assessed within 30 days of study inclusion
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Chest pain
Временное ограничение: Assessed within 30 days of study inclusion
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Canadian Cardiovascular Society angina pectoris class |
Assessed within 30 days of study inclusion
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Major cardiovascular events
Временное ограничение: Assessed 1 year after Cardiac CT imaging
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Composite endpoint of either death, myocardial infarction, heart failure or stroke |
Assessed 1 year after Cardiac CT imaging
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Учебный стул: Peter Damm, MD, DmSc, Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
Публикации и полезные ссылки
Общие публикации
- Hauge MG, Damm P, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Moller MB, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Early Coronary Atherosclerosis in Women With Previous Preeclampsia. J Am Coll Cardiol. 2022 Jun 14;79(23):2310-2321. doi: 10.1016/j.jacc.2022.03.381.
- Hauge MG, Damm P, Kofoed KF, Moller ELR, Lopez AG, Ersboll AS, Johansen M, Sigvardsen PE, Pham MHC, Goetze JP, Fuchs A, Kuhl JT, Nordestgaard BG, Kober LV, Gustafsson F, Linde JJ. Left Ventricular Hypertrophy in Women With a History of Preeclampsia. Hypertension. 2025 May;82(5):774-783. doi: 10.1161/HYPERTENSIONAHA.124.23497. Epub 2024 Nov 14.
- Hauge MG, Linde JJ, Kofoed KF, Ersboll AS, Johansen M, Sigvardsen PE, Fuchs A, Mikkelsen AP, Gustafsson F, Damm P. Early-onset vs late-onset preeclampsia and risk of coronary atherosclerosis later in life: a clinical follow-up study. Am J Obstet Gynecol MFM. 2024 May;6(5):101371. doi: 10.1016/j.ajogmf.2024.101371. Epub 2024 Apr 6.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
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
- H-18065695
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Logistics and patient data protection issues will be explored prior to decision on IPD
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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