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临床试验/NCT05440084
NCT05440084终止不适用

Impact of Chronic Total Occlusion Percutaneous Coronary Intervention on Regular Physical Activity

Minneapolis Heart Institute Foundation1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Change in daily steps compared with baseline

研究概览

简要总结

Heart disease is a leading cause of death in the US. . Heart blood vessel chronic total occlusions are 100% blockages of the heart vessels. These patients often suffer from chest pain, shortness of breath, and depression. Heart doctors thread special cables from the groin and wrist to the heart and open up these 100% blocked vessels. . This treatment improves symptoms and quality of life. Exercise is very beneficial for health. Previous studies suggest that even a 1000 steps/day increase in daily steps can improve health. But, patients with occluded heart vessels are often inactive because they have chest pain, feeling tired, or are short of breath. It is unknown whether opening these 100% blocked heart vessels will help patients have a more active lifestyle, which is good for health. The goal is to measure the impact of opening these occluded heart vessels on daily exercise in this project. Specifically, the investigators will give a smart watch to patients referred for this treatment. The smart watch will track the patients' daily steps before and after the procedure.

详细描述

The investigators will compare the daily steps before and after the procedure to understand if the patients are more active. In addition to tracking daily steps, The investigators will track calorie expenditure with the watch.

The investigators will also use surveys to evaluate chest pain and depression. In sum, the investigators will study the impact of opening occluded heart vessels on daily exercise. If the investigators find that this routinely used treatment leads to increased daily steps, the investigators will know better which patients this treatment can help live longer and healthier

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

  • Age 18 years or older
  • Willing and able to provide informed consent
  • Patients referred for clinically indicated CTO-PCI
  • Access to smart phone (Apple or Android platform)
  • Willing and able to wear a smart watch
  • Clinically stable and able to walk/ exercise independently

排除标准

  • Inability to exercise due to non-cardiac problems (e.g., orthopedic restrictions, amputation, musculoskeletal/neurological disease affecting mobility etc.-as determined by investigator discretion)
  • Plan for major surgical procedure (other than CTO PCI) which would limit exercise capability
  • Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.

结局指标

主要结局

Change in daily steps compared with baseline

时间窗: 3 Months

Significant change in daily steps at 3-month follow-up (as measured by smart watch)

次要结局

  • Change in calorie expenditure(3 Months)
  • Change in Seattle Angina Questionnaire-7 (SAQ-7) summary score follow-up compared with baseline(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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