Post-Pregnancy Cardio Trial
PPC1
Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)
1 other identifier
observational
47
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2017
CompletedFirst Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJuly 26, 2018
July 1, 2018
10 months
October 13, 2017
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
any structural or functional change of the heart (combined outcome)
Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy
0.5 - 20 years after delivery
Secondary Outcomes (6)
myocardial fibrosis
0.5 - 20 years after delivery
myocardial edema
0.5 - 20 years after delivery
myocardial fat infiltrates
0.5 - 20 years after delivery
myocardial inflammation
0.5 - 20 years after delivery
myocardial hypertrophy
0.5 - 20 years after delivery
- +1 more secondary outcomes
Study Arms (2)
PE
Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum
Control
Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum
Eligibility Criteria
Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia diagnosis during index pregnancy or without pathological findings. Controls are matched to cases based on age and BMI.
You may qualify if:
- postpartal window: 0.5 - 20 years
- cases: diagnosis of preeclampsia during the index pregnancy
- controls: age and BMI matched
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Experimental and Clinical Research Center (ECRC)
Berlin, 13125, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 18, 2017
Study Start
August 28, 2017
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
July 26, 2018
Record last verified: 2018-07