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Endothelial dysfunction and CArdiovascular Risk after PreEclampsia (CARPE)



Short title: CARPE

Investigated disease: Preeclampsia

Principal Investigator: Dr. rer. medic. Kristin Kräker


Clinic, Institute: Experimental and Clinical Research Center (ECRC)

Patient (diseased)
Age: 18 - 60
Gender: Female

Status: Participants wanted
Last change: 08.02.2023

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Study Description

Title

Endothelial dysfunction and CArdiovascular Risk after PreEclampsia (CARPE)

Short title

CARPE

General Short Description

Epidemiological studies have shown that preeclamptic pregnancy increases cardiovascular risk up to fourfold. In this study we want to investigate vascular function at different sites (myocardium, upper arm, fingertips, retina) and identify possible biomarkers for early detection of increased long-term risk 5 to 15 years after a preeclamptic pregnancy.

Scientific Short Description

The object of this pilot study is to analyze vascular endothelial function in order to obtain conclusions about the severity of end-organ damage after preeclamptic pregnancy. The main objective of this case-control study is to define cardiovascular changes by magnetic resonance imaging and to correlate them with the results of non-invasive methods such as retinal vascular analysis, finger plethysmography or analysis of advanced glycation endproducts and thereby establish possible biomarkers for early detection. Here, the study will be performed in women 5-15 years after preeclampsia and age-matched women after pregnancy without preeclampsia. Cardiovascular changes in women after early and after late preeclampsia will be differentiated.

Website (Charité)WebsitePrimary Register Type

ClinicalTrials.gov-No. (NCT)

Primary Register-ID

NCT05277233

Study start

04.04.2022

Investigated Disease, Health Issue

ICD-Code
  • O14 - Präeklampsie

Inclusion Criteria

Age

18 - 60

Gender

Female

Additional Inclusion Criteria
  • 5 to 15 years after first preeclamptic pregnancy
  • 5 to 15 years after first healthy pregnancy (controls)

Exclusion Criteria

  • Refusal to participate in the study
  • Incapacity or other circumstances that do not allow subjects to fully understand the nature, significance, and scope of this study
  • MRI contraindications: Metal implants in the body, intolerance to contrast media, wearing pacemakers or defibrillators, claustrophobia, renal or hepatic dysfunction
  • Hypertension before first pregnancy
  • AV block, COPD, bronchial asthma
  • Pregnancy and/or active breastfeeding
  • Glaucoma disease, epilepsy

Characteristics

Studytype

Non-interventional

Studyphase

N/A

Primary Outcome

myocardial perfusion | measured by adenosine magnetic resonance imaging

Secondary Outcome

- myocardial fibrosis | measured by magnetic resonance imaging
- end-diastolic volume and left ventricular stroke volume | measured by magnetic resonance imaging
- circulating T cells in the blood | measured by isolation of peripheral venous blood mononuclear cells
- serum natriuretic peptide | measured in blood serum
- unrinary protein and creatinine | measured in spontaneous urine
- autofluorescence of the skin | measured with AGE Reader
- body fat percentage | measured by bioimpedance analysis
- hand grip strength | measured with dynamometer
- systolic and diastolic central blood pressure and pulse wave velocity | measured with Mobil-O-Graph and PulsePen
- flow-mediated vasodilation of the brachial artery | measured with UNEX EF 38G
- reactive hyperemia index | measured by plethysmography on the index finger by EndoPat 2000
- choroidal thickness and retinal macular volume | measured with fundus camera and optical coherence tomography
- dilation capacity and recovery time of retinal vessels upon stimulation with flicker light | measured with Dynamic Vessel Analyser
- estimate and monitor cardiovascular and pulmonary performance below the anaerobic threshold | 6-min walk test

Intervention Groups, Observation Groups

  • Arm 1

    women after early preeclampsia

  • Arm 2

    women after late preeclampsia

  • Arm 3

    women after healthy pregnancy

Contact

Contact for Study Participants

Frau Heike Schenck

030 450540 565

heike.schenck(at)charite.de


Contact for Scientific Inquiries

Frau Dr.rer.nat. Kristin Kräker

030 450540 328

kristin.kraeker(at)charite.de


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