The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiovascular Disease After Preeclampsia

Conditions
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Pre-Eclampsia, Atherosclerosis, Cardiovascular Diseases, Heart Disease in Women

Intervention / Treatment
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* Diagnostic Test: Cardiovascular CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Cardiovascular CT|Cardiac and cardiovascular non-contrast and contrast CT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary atherosclerosis | Presensence of coronary plaque as defined by Cardiac CT | Assessed within 30 days of study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of left bundle branch block | Electrocardiographic abnormality | Assessed within 30 days of study inclusion | 
| Presence of atrial fibrillation | Electrocardiographic abnormality | Assessed within 30 days of study inclusion | 
| Presence of T-wave inversion | Electrocardiographic abnormality | Assessed within 30 days of study inclusion | 
| Presence of left ventricular hypertrophy | Electrocardiographic abnormality | Assessed within 30 days of study inclusion | 
| Arterial hypertension | Presence of elevated blood pressure | Assessed within 30 days of study inclusion | 
| Dyspnoe | New York Heart Association class | Assessed within 30 days of study inclusion | 
| Chest pain | Canadian Cardiovascular Society angina pectoris class | Assessed within 30 days of study inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre- eclampsia, Heart disease in women