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临床试验/NCT04485754
NCT04485754已完成不适用

Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients

Tomsk National Research Medical Center of the Russian Academy of Sciences2 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2020年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
MACCE

研究概览

简要总结

The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients

详细描述

Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.

研究设计

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

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Age ≥ 40 years
  • PCI with coronary artery stenting for ACS
  • Angiographic success PCI

排除标准

  • Patients with cancer
  • Severe CHF (EF LV <35% or functional class of heart failure III-IV NYHA)
  • Severe valvular heart disease or Prosthetic heart valves.
  • Severe forms of CKD (GFR<30mL/min)
  • Planned staged revascularization during the next 12 months
  • Planned surgery within the next 12 months

研究组 & 干预措施

Telemedicine FU

Experimental

Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

干预措施: Telemedicine FU (Other)

Office FU

Active Comparator

Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.

干预措施: Office FU (Other)

结局指标

主要结局

MACCE

时间窗: 1 year

Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke

次要结局

  • Decrease in overweight(1 year)
  • Adherence to prescribed medication(1 year)
  • Hospitalization(1 year)
  • PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)(1 year)
  • LDL < 1.4 mmol/L(1 year)
  • Not smoking(1 year)
  • Aspirin or other antiplatelet or anticoagulant(1 year)
  • High level of MT optimization(1 year)

研究者

研究点 (2)

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