Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-01 @ 9:34 AM
Study NCT ID:
NCT04234659
Status:
UNKNOWN
Last Update Posted:
2021-12-13
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PPCM Observational Study (Peripartum Cardiomyopathy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000099088', 'term': 'Peripartum Cardiomyopathy'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D011249', 'term': 'Pregnancy Complications, Cardiovascular'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.', 'timeFrame': 'From onset of event through 90 days after participant enrollment.', 'description': 'The retrospective and prospective data collected from study participants will report clinical treatments required to treat the diagnosis of peripartum cardiomyopathy complicated by cardiogenic shock.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripartum Cardiomyopathy', 'Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '26293760', 'type': 'BACKGROUND', 'citation': 'McNamara DM, Elkayam U, Alharethi R, Damp J, Hsich E, Ewald G, Modi K, Alexis JD, Ramani GV, Semigran MJ, Haythe J, Markham DW, Marek J, Gorcsan J 3rd, Wu WC, Lin Y, Halder I, Pisarcik J, Cooper LT, Fett JD; IPAC Investigators. Clinical Outcomes for Peripartum Cardiomyopathy in North America: Results of the IPAC Study (Investigations of Pregnancy-Associated Cardiomyopathy). J Am Coll Cardiol. 2015 Aug 25;66(8):905-14. doi: 10.1016/j.jacc.2015.06.1309.'}, {'pmid': '24901108', 'type': 'BACKGROUND', 'citation': 'Kolte D, Khera S, Aronow WS, Palaniswamy C, Mujib M, Ahn C, Jain D, Gass A, Ahmed A, Panza JA, Fonarow GC. Temporal trends in incidence and outcomes of peripartum cardiomyopathy in the United States: a nationwide population-based study. J Am Heart Assoc. 2014 Jun 4;3(3):e001056. doi: 10.1161/JAHA.114.001056.'}, {'pmid': '30963079', 'type': 'BACKGROUND', 'citation': 'Doerr M, Grayson S, Moore S, Suver C, Wilbanks J, Wagner J. Implementing a universal informed consent process for the All of Us Research Program. Pac Symp Biocomput. 2019;24:427-438.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.', 'detailedDescription': 'This single-site, virtual, longitudinal, observational study will investigate two cohorts (study groups) by enrolling a total of ten participants, five in each cohort. The two cohorts include individuals who received mechanical circulatory support (specifically the IMPELLA® device) compared to individuals who did not receive mechanical circulatory support for treatment of their PPCM complicated by cardiogenic shock index event.\n\nThe duration of enrollment for each participant is about 5 months. It is anticipated that the trial will be complete in 12 months. Participant engagement to the study will be self-initiated.\n\nUnder the guidance and support of Medical College of Wisconsin research coordinator, participants will directly access the study REDCapTM database for enrollment and follow-up data entry for this study. The research coordinator will obtain and abstract participant medical records documenting the event.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females meeting study eligibility criteria who have been diagnosed and treated clinically for peripartum cardiomyopathy complicated by cardiogenic shock. A total of 10 participants will be enrolled in each of the two study cohorts (groups).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemales:\n\n* age ≥ 18 years old at the time of entry into the study\n* who have capacity to provide consent for study participation\n* with self-reported PPCM complicated by cardiogenic shock\n* individuals should have US citizenship\n* index event occurring within the continental United States.\n\nExclusion Criteria:\n\n* lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition\n* inability of participant to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04234659', 'briefTitle': 'PPCM Observational Study (Peripartum Cardiomyopathy)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Observational Study for Outcomes for Participants With Cardiogenic Shock and Peripartum Cardiomyopathy', 'orgStudyIdInfo': {'id': 'PRO35709'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals Receiving Mechanical Circulatory Device Support', 'description': 'Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.', 'interventionNames': ['Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.']}, {'label': 'Individuals Without Mechanical Circulatory Device Support', 'description': 'Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.'}], 'interventions': [{'name': 'Clinical placement of a temporary IMPELLA® mechanical circulatory support device.', 'type': 'DEVICE', 'description': 'Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.', 'armGroupLabels': ['Individuals Receiving Mechanical Circulatory Device Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary C Wexler, BS', 'role': 'CONTACT', 'email': 'mwexler@mcw.edu', 'phone': '414-955-6741'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Susan K. Mauermann, RN', 'role': 'CONTACT', 'email': 'smauerma@mcw.edu', 'phone': '414-955-6749'}, {'name': 'Mary C Wexler, BS', 'role': 'CONTACT', 'email': 'mwexler@mcw.edu', 'phone': '414-955-6741'}], 'overallOfficials': [{'name': 'Sarah Thordsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abiomed Inc.', 'class': 'INDUSTRY'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Cardiovascular Medicine', 'investigatorFullName': 'Sarah Thordsen', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}