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临床试验/NCT04415762
NCT04415762已完成不适用

A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)

San Luigi Gonzaga Hospital0 个研究点目标入组 314 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
314
主要终点
Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)

研究概览

简要总结

The study will investigate the clinical features, acute management and follow up of patients affected by spontaneous coronary artery dissection

详细描述

Spontaneous Coronary Artery Dissection is now being increasingly studied as it is getting more and more relevant as a cause of ACS. Its management is currently a matter of debate due to the absence of RCT and even the trigger events related to this kind of infarction are still unclear. Notably, the benefits from the use of the antiplatelet medications that prolong bleeding time for a condition whose primary pathophysiology may be an intramural bleed are under discussion.

Hence, the targets pursued by our study may be essentially distinguished in five main points:

  1. To assess the characteristics of SCAD patients highlighting the predisposing and precipitating factors related to the acute event
  2. To analyze clinical presentation and management of spontaneous coronary dissections in terms of therapeutic approach in the acute phase (conservative therapy vs revascularization)
  3. To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events (MACEs) at follow-up
  4. To analyze the impact of a single antiplatelet therapy (SAPT) over the dual one (DAPT) along with the impact of different P2Y12i regimens on acute and long-term prognosis
  5. To evaluate impact of different angiographic SCAD type on outcome

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
All
接受健康志愿者

入选标准

  • Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD)

排除标准

  • Age <18 year old or inability to provide Informed Consent

结局指标

主要结局

Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)

时间窗: 12 months

Major Cardiovascular Cardiac Events occurring within 12 months

次要结局

  • non-fatal Myocardial Infarction (MI)(12 months)
  • any unplanned revascularization either percutaneous or surgical(12 months)
  • all-cause of death(12 months)

研究者

发起方
San Luigi Gonzaga Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Cerrato

Principal Investigator

San Luigi Gonzaga Hospital

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