Post-Pregnancy Cardio Trial

NCT ID: NCT03313063

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-06-30

Brief Summary

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Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.

Detailed Description

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Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PE

Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum

No interventions assigned to this group

Control

Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* postpartal window: 0.5 - 20 years
* cases: diagnosis of preeclampsia during the index pregnancy
* controls: age and BMI matched

Exclusion Criteria

* metal implants
* kidney insufficiency (GFR \< 30 ml/min/)
* claustrophobia
* contrast medium allergy
* current pregnancy/ lactation
* chronic hypertension (\> 140/90)
* diagnosis of previous cardiovascular disease
* body weight over 120 kg
* big tattoos in thorax area
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Florian Herse

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Experimental and Clinical Research Center (ECRC)

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PPC1

Identifier Type: -

Identifier Source: org_study_id

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