Observational Study for Outcomes for Participants With Cardiogenic Shock and Peripartum Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.
研究概览
简要总结
The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition
- •inability of participant to provide informed consent
研究组 & 干预措施
Individuals Receiving Mechanical Circulatory Device Support
Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.
干预措施: Clinical placement of a temporary IMPELLA® mechanical circulatory support device. (Device)
Individuals Without Mechanical Circulatory Device Support
Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.
结局指标
主要结局
Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.
时间窗: 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.
次要结局
未报告次要终点
研究者
Sarah Thordsen
Assistant Professor Cardiovascular Medicine
Medical College of Wisconsin