Cardiogenic Shock, Peripartum Cardiomyopathy
Conditions
Brief summary
The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.
Detailed description
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. The 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. Under 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.
Interventions
DEVICEClinical placement of a temporary IMPELLA® mechanical circulatory support device.
Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.
Sponsors
Medical College of Wisconsin
Abiomed Inc.
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Females: * age ≥ 18 years old at the time of entry into the study * who have capacity to provide consent for study participation * with self-reported PPCM complicated by cardiogenic shock * individuals should have US citizenship * index event occurring within the continental United States.
Exclusion criteria
* lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition * inability of participant to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock. | From onset of event through 90 days after participant enrollment. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Thordsen, MD
Medical College of Wisconsin
Outcome results
None listed