Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 2:22 AM
Study NCT ID:
NCT05277233
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk After Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum, peripheral blood mononuclear cells (PBMCs)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial perfusion', 'timeFrame': 'Day 2', 'description': 'Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)'}], 'secondaryOutcomes': [{'measure': 'Cardiac fibrosis', 'timeFrame': 'Day 2', 'description': 'Measured by Magnetic Resonance Imaging (g)'}, {'measure': 'Immune cell phenotypes', 'timeFrame': 'Day 1', 'description': 'Measured in isolated peripheral blood mononuclear cells'}, {'measure': 'Concentration of N-terminal prohormone of brain natriuretic peptide', 'timeFrame': 'Day 1', 'description': 'Measured in serum (ng/l)'}, {'measure': 'Concentration of brain natriuretic peptide', 'timeFrame': 'Day 1', 'description': 'Measured in serum (ng/l)'}, {'measure': 'Urinary protein', 'timeFrame': 'Day 1', 'description': 'Measured in spot urine (mg)'}, {'measure': 'Advanced glycation end products', 'timeFrame': 'Day 1', 'description': 'Measured by skin autofluorescence (arbitrary units)'}, {'measure': 'Body fat mass', 'timeFrame': 'Day 1', 'description': 'Measured by bioimpedance analysis (%)'}, {'measure': 'Body fat-free mass', 'timeFrame': 'Day 1', 'description': 'Measured by bioimpedance analysis (%)'}, {'measure': 'Hand grip strength', 'timeFrame': 'Day 1', 'description': 'Measured by dynamometer (kg)'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Day 1', 'description': 'Mean of three consecutive blood pressure measurements (mmHg)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Day 1', 'description': 'Mean of three consecutive blood pressure measurements (mmHg)'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'Day 1', 'description': 'Calculated by algorithm based on age and blood pressure values (m/s)'}, {'measure': 'Flow-mediated dilation', 'timeFrame': 'Day 1', 'description': 'Measured by brachial artery diameter (µm)'}, {'measure': 'Reactive hyperemia index', 'timeFrame': 'Day 1', 'description': 'Measured by finger plethysmography'}, {'measure': 'Choroidal thickness', 'timeFrame': 'Day 1', 'description': 'Measured with Optical Coherence Tomography (µm)'}, {'measure': 'Macular volume', 'timeFrame': 'Day 1', 'description': 'Measured with Optical Coherence Tomography (mm³)'}, {'measure': 'Arterial dilation induced by retinal flicker stimulation', 'timeFrame': 'Day 1', 'description': 'Measured with Dynamic Vessel Analyser (seconds)'}, {'measure': 'Venous dilation induced by retinal flicker stimulation', 'timeFrame': 'Day 1', 'description': 'Measured with Dynamic Vessel Analyser (seconds)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Woman 5-15 years after pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* 18-60 years\n* 5-15 years postpartum\n\nExclusion Criteria:\n\n* Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma\n* Pregnancy and/or active breastfeeding\n* Glaucoma disease, epilepsy\n* In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR \\< 30 ml/min)'}, 'identificationModule': {'nctId': 'NCT05277233', 'briefTitle': 'Cardiovascular Risk After Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia', 'orgStudyIdInfo': {'id': 'CARPE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early-onset preeclampsia', 'description': 'Defined as preeclampsia that develops before 34 weeks of gestation'}, {'label': 'Late-onset preeclampsia', 'description': 'Defined as preeclampsia that develops after 34 weeks of gestation'}, {'label': 'Control', 'description': 'Healthy pregnancies, matched to early and late-onset cases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13125', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anja Mähler, PhD', 'role': 'CONTACT', 'email': 'anja.maehler@charite.de', 'phone': '+49 30 450540 323'}, {'name': 'Kristin Kräker, PhD', 'role': 'CONTACT', 'email': 'kristin.kraeker@charite.de', 'phone': '+49 30 450540 328'}, {'name': 'Jeanette Schulz-Menger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ralf Dechend, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Experimental and Clinical Research Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Kristin Kräker, PhD', 'role': 'CONTACT', 'email': 'kristin.kraeker@charite.de', 'phone': '+49 30 450540 328'}], 'overallOfficials': [{'name': 'Anja Mähler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristin Kraeker', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}