CoPenHagen PREeClampsia および cardIOvascUlar 疾患研究 (CPH-PRECIOUS)
子癇前症後の心血管疾患
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Copenhagen、デンマーク、2100
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
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Copenhagen、デンマーク、2100
- Department of Obstetrics, Rigshospitalet
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Herlev、デンマーク、2730
- The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Coronary atherosclerosis
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of left bundle branch block
時間枠：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
時間枠：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 T-wave inversion
時間枠：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 left ventricular hypertrophy
時間枠：Assessed within 30 days of study inclusion
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Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
|
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Arterial hypertension
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Major cardiovascular events
時間枠：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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協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア：Peter Damm, MD, DmSc、Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H-18065695
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Logistics and patient data protection issues will be explored prior to decision on IPD
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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