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出境医 / 临床实验 / The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study (CPH-PRECIOUS)

The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study (CPH-PRECIOUS)

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Pre-Eclampsia Atherosclerosis Cardiovascular Diseases Heart Disease in Women Diagnostic Test: Cardiovascular CT

Detailed Description:

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

  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
  4. 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.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 921 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cardiovascular Disease After Preeclampsia
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : January 30, 2021
Estimated Study Completion Date : June 30, 2031
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Coronary atherosclerosis [ Time Frame: Assessed within 30 days of study inclusion ]
    Presensence of coronary plaque as defined by Cardiac CT


Secondary Outcome Measures :
  1. Presence of left bundle branch block [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  2. Presence of atrial fibrillation [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  3. Presence of T-wave inversion [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  4. Presence of left ventricular hypertrophy [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality

  5. Arterial hypertension [ Time Frame: Assessed within 30 days of study inclusion ]
    Presence of elevated blood pressure

  6. Dyspnoe [ Time Frame: Assessed within 30 days of study inclusion ]
    New York Heart Association class

  7. Chest pain [ Time Frame: Assessed within 30 days of study inclusion ]
    Canadian Cardiovascular Society angina pectoris class


Other Outcome Measures:
  1. Major cardiovascular events [ Time Frame: Assessed 1 year after Cardiac CT imaging ]
    Composite endpoint of either death, myocardial infarction, heart failure or stroke


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 8, 2019
First Posted Date May 14, 2019
Last Update Posted Date May 18, 2021
Actual Study Start Date May 20, 2019
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2019)
Coronary atherosclerosis [ Time Frame: Assessed within 30 days of study inclusion ]
Presensence of coronary plaque as defined by Cardiac CT
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2019)
  • Presence of left bundle branch block [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality
  • Presence of atrial fibrillation [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality
  • Presence of T-wave inversion [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality
  • Presence of left ventricular hypertrophy [ Time Frame: Assessed within 30 days of study inclusion ]
    Electrocardiographic abnormality
  • Arterial hypertension [ Time Frame: Assessed within 30 days of study inclusion ]
    Presence of elevated blood pressure
  • Dyspnoe [ Time Frame: Assessed within 30 days of study inclusion ]
    New York Heart Association class
  • Chest pain [ Time Frame: Assessed within 30 days of study inclusion ]
    Canadian Cardiovascular Society angina pectoris class
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2019)
Major cardiovascular events [ Time Frame: Assessed 1 year after Cardiac CT imaging ]
Composite endpoint of either death, myocardial infarction, heart failure or stroke
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Official Title Cardiovascular Disease After Preeclampsia
Brief Summary

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

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

  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
  4. 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Probability Sample
Study Population 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.
Condition
  • Pre-Eclampsia
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Disease in Women
Intervention Diagnostic Test: Cardiovascular CT
Cardiac and cardiovascular non-contrast and contrast CT
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 16, 2021)
921
Original Estimated Enrollment
 (submitted: May 11, 2019)
1000
Estimated Study Completion Date June 30, 2031
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 35 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03949829
Other Study ID Numbers H-18065695
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Logistics and patient data protection issues will be explored prior to decision on IPD
Responsible Party Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
Study Sponsor Klaus Fuglsang Kofoed
Collaborators Herlev Hospital
Investigators
Study Chair: Peter Damm, MD, DmSc Department of Obstetrics, Rigshospitalet, University of Copenhagen, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date May 2021