- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03949829
CoPenHagen PREeClampsia 및 cardIOvascUlar 질병 연구 (CPH-PRECIOUS)
자간전증 후 심혈관 질환
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
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Copenhagen, 덴마크, 2100
- Department of Obstetrics, Rigshospitalet
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Herlev, 덴마크, 2730
- The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Coronary atherosclerosis
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Presence of left bundle branch block
기간: 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
기간: 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
기간: Assessed within 30 days of study inclusion
|
Electrocardiographic abnormality |
Assessed within 30 days of study inclusion
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Presence of left ventricular hypertrophy
기간: 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
기간: 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
기간: Assessed within 30 days of study inclusion
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New York Heart Association class |
Assessed within 30 days of study inclusion
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Chest pain
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major cardiovascular events
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Peter Damm, MD, DmSc, Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-18065695
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Logistics and patient data protection issues will be explored prior to decision on IPD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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