Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD): A Collaborative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- First Major Adverse Cardiovascular Event (post-SCAD)
研究概览
简要总结
This multi-site international clinical research project is a collaboration between investigators from multiple institutions in the USA, Canada, and Europe. Approximately 7 to 11 sites will participate and provide data for analysis. Clinical operations (for data collection and analysis) across sites will be managed by Stanford. The study purpose is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peripartum and non-peripartum SCAD patients.
详细描述
There is a reason to believe that female sex hormone fluctuations during the peripartum period are linked with the occurrence of SCAD, and may be associated with a distinctive clinical presentation. In addition, symptoms of psychological distress may be linked to the development of SCAD and post-event distress is higher in SCAD patients than in those with coronary artery disease (CAD).
The primary objective is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients. At the methodological level, the purpose is to apply a systematic image analysis protocol for classifying SCAD lesions and to pool data to achieve adequate statistical power.
The secondary objective is to gather more information about psychological and psychosocial factors in SCAD patients. Specifically, to assess pre-event stress and psychological diagnoses and determine differences in post-event distress between peripartum and non-peripartum SCAD.
It is expected that these aims will result in two important outcomes. First, implementation of a systematic image analysis protocol for SCAD data will lead to improved reliability and, we expect, the detection of clinically meaningful differences between peripartum and non-peripartum SCAD. These differences may align with potential causal mechanisms for further study to ultimately better understand SCAD and develop treatment(s). Second, by characterizing the psychological distress experienced by SCAD patients, and differences between patients who experienced peripartum vs. non-peripartum SCAD, psychosocial risk factors may be identified and psychosocial interventions can be tailored to meet the needs of this unique patient population.
This is an observational study using cross-sectional design. There are two main components: a retrospective collection of medical history pertaining to SCAD event and prospective questionnaires. Sites may elect not to contact patients and not collect the prospective questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Sites contacting patients and/or conducting the survey
- •Female adults 18 years of age and older
- •Voluntary participation
- •Patients with a known or suspected diagnosis of SCAD
- •Ability to read in English
- •Ability to access online consent and questionnaire portal
- •Sites not contacting patients and/or conducting the survey
- •Female adults 18 years of age and older
- •Patients with a known or suspected diagnosis of SCAD
- •Exclusion Criteria
- •Not fulfilling inclusion criteria
排除标准
- 未提供
结局指标
主要结局
First Major Adverse Cardiovascular Event (post-SCAD)
时间窗: First SCAD event represents t=0. Time (in days) from t=0 until the first occurrence of any of the above, for up to 6-months after t=0.
The time from the first SCAD event until the first occurrence of (1) myocardial infarction, (2) re-vascularization, (3) stroke, or (4) death due to cardiovascular cause.
次要结局
- Stress(At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.)
- Depression(At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.)
- Anxiety(At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.)
- Post-Traumatic Stress Disorder(At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.)
研究者
Katharine Sears Edwards
Clinical Assistant Professor, Medicine - Cardiovascular Medicine
Stanford University