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临床试验/NCT07491744
NCT07491744Enrolling By Invitation不适用

The SALSA Study - Investigating the Effect of Extended Assessment of Stroke Aetiology and Vascular Disease on the Risk of Recurrence.

Region Stockholm1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
600
试验地点
1
主要终点
Number of major adverse cardiovascular events (MACE)

研究概览

简要总结

Annually, about 4000 Swedes suffer a recurrent stroke, and for many, their lives change dramatically. To prevent recurring strokes, knowledge about the individual's risk of recurrence is needed to tailor an effective preventive medical treatment.

The purpose of the SALSA study is to investigate whether an expanded risk assessment and subsequent treatment can reduce the recurrence of stroke in study patients. Stroke, i.e., infarction/bleeding in the brain, has several different causes that individually or together constitute the risk of recurrence. Furthermore, stroke patients often have concomitant vascular diseases in other vascular beds, which further increases the risk.

Every fourth patient with acute stroke or transient ischemic attack (TIA) admitted to any of the stroke wards at Danderyd Hospital, Stockholm, Sweden, is consecutively invited to participate in the SALSA study. Those who accept the study invitation, receive an expanded investigation of the most common causes of cerebral infarction (atherosclerosis, atrial fibrillation, narrowing of the brain's small vessels) or brain haemorrhage (presence of the protein amyloid in the vessels, high blood pressure). Due to the high risk of stroke patients having a vascular disease, such as atherosclerosis, the presence of arterial stiffness in the aorta, 24-hour blood pressure, and blood circulation in the legs are examined at the follow-up visit. If vascular disease is detected, expanded preventive treatment is provided. Neither a general investigation of the most common stroke aetiologies in addition to the one assessed to have caused the current stroke nor examinations of other vascular beds are recommended in national stroke guidelines. In addition to the extended risk assessment, the patient will get a written treatment program tailored after the individual patient's risk profile. The compliance to this treatment program will be assessed during a return visit one year after the hospital stay. After this visit, the active participation in the study is completed for the study participant. During the remainder of the follow-up, the study participant will be followed in national medical registers.

The remaining 3/4 of patients at Danderyd Hospital constitute the comparison group, who are investigated and treated according to routine and hence do not undergo the additional vascular examinations. Stroke recurrence and other cardiovascular events occurring within the next 5-10 years will be compared between study patients and the comparison group via the national stroke registry containing all stroke and TIA patients at Danderyd Hospital.

详细描述

Background

Stroke and TIA are caused by circulatory disorders in the cerebral vasculature, but the etiological mechanisms vary greatly. In clinical practice in Sweden today, stroke and TIA patients are investigated with the aim of finding the primary cause of the acute ischemic event, after which preventive treatment is initiated. Beyond identifying the proposed causative aetiology, concomitant subclinical stroke aetiologies and risk factors are not routinely examined, despite the fact that presence of multiple cerebrovascular aetiologies are likely to pose an increased risk of stroke recurrence. Moreover, national guidelines do not recommend a complete etiological assessment or screening for other vascular diseases in acute stroke and TIA patients, even though general vascular disease poses an increased risk for recurrent vascular events. This complicates the shift towards individualized preventive treatment based on a risk stratification strategy.

Aims/Hypotheses

The aim of the SALSA study is to investigate in a consecutive, representative hospital population with stroke and TIA patients (study cohort):

  1. The prevalence of one/multiple cerebrovascular disease aetiologies classified according to known classification systems such as TOAST and ASCOD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Admitted to the Danderyd Hospital Stroke Unit for acute stroke or TIA

排除标准

  • The medical condition is assessed not to be a stroke or TIA
  • The patient is not able to make an informed decision to enter the study

结局指标

主要结局

Number of major adverse cardiovascular events (MACE)

时间窗: Total follow up of each study participant is up to 15 years.

MACE = cardiovascular death, non-fatal myocardial infarction and stroke

次要结局

  • Number of stroke(Total follow up of each study participant is up to 15 years.)
  • Number of myocardial infarctions(Total follow up of each study participant is up to 15 years.)
  • Number of cardiovascular deaths(From inclusion in the study until December 31st 2036)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Louise Dencker Ziegler

Principal Investigator

Region Stockholm

研究点 (1)

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