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临床试验/NCT04906356
NCT04906356招募中不适用

Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)

Cardiology Research UBC1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
In-hospital CV outcomes

研究概览

简要总结

Natural history multicenter, prospective, observational registry with 10-year follow-up

详细描述

Spontaneous coronary artery dissection (SCAD) is an under-diagnosed and poorly understood condition that frequently affects young women without conventional cardiovascular (CV) risk factors and can result in myocardial infarction (MI), cardiac arrest, and death. This condition has not been adequately studied, and there are no randomized controlled trials to guide treatment. Furthermore, SCAD has been frequently misdiagnosed due to the current "gold-standard" coronary angiography limitations. As such, there are uncertainties with the diagnosis and management of SCAD patients. Therefore, the investigators propose a large prospective multicenter Canadian SCAD Study to ascertain the natural history of predisposing arteriopathies and treatment strategy on short and long-term CV outcomes to design future randomized controlled trials.

This is a multicenter, prospective, international, observational natural history study with a planned total enrolment of 3,000 patients with SCAD. The investigators plan to recruit patients from major cardiac catheterization centers across Canada and several centers in the United States and internationally. The research team successfully enrolled 750 patients prospectively in the "Canadian SCAD Cohort Study" from 22 sites in North America. This current study will be an extension of that study, now named the "Canadian SCAD Study." It will continue enrolment for a total of 3,000 patients internationally (from >35 sites). Detailed baseline demographics, targeted history for precipitating stressors and predisposing conditions, and investigations for predisposing conditions will be performed during the study. Patients will be prospectively followed long-term for up to 10 years for CV events. The study is approved, allowing potential participants to be enrolled using an electronic consent form irrespective of their geographic location and directly communicating with the study team at UBC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients admitted with ACS (STEMI, NSTEMI or unstable angina)
  • Documented SCAD on a coronary angiogram (including diagnosis with OCT or IVUS)

排除标准

  • Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%

结局指标

主要结局

In-hospital CV outcomes

时间窗: From date of hospital admission to discharge up to 8 weeks

Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)

Long-term CV outcomes

时间窗: at 10 Years post index event

Composite (Death, MI, CVA, Revascularization, Heart failure)

次要结局

  • Arterial healing post SCAD(at 6 weeks post discharge post index event)
  • Coronary revascularization success(During index hospitalization)

研究者

发起方
Cardiology Research UBC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacqueline Saw, MD

Clinical Professor of Medicine

Cardiology Research UBC

研究点 (1)

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