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临床试验/CTRI/2024/07/071055
CTRI/2024/07/071055已完成不适用

Co-relation of coronary angiography after STEMI with ECG recording via portable smartphone based ECG device(Spandan).

Sunfox Technologies Private Limited1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The primary outcome measure is the correlation between ECG recordings obtained via smartphone-based portable ECG devices and the findings of coronary angiography.

研究概览

简要总结

The study is designed as an observational study focusing on collecting and analyzing data from patients with ST-segment elevation myocardial infarction (STEMI) who receive both smartphone-based portable ECG recordings and coronary angiography as part of their clinical care in  100 to140 patients. It includes subjects ages above 18-75 years. and the subject has symptoms like Chest pain, shortness of breath, or pulse and also patients referred for Coronary Angiography. The primary outcome measures whether Spandan ECG can detect the occluded artery. Compared with angiography, the secondary outcome measures how precisely it determines the coronary artery occlusion.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients should have symptoms such as chest pain palpitations and shortness of breath.
  • These symptoms are indicative of potential cardiac issues and make them suitable candidates for the study and Patients referred for coronary angiography are included.

排除标准

  • History of Reperfusion: Patients with a history of reperfusion therapy are excluded.
  • This criterion may be in place to focus on patients who have not undergone reperfusion and to avoid potential confounding factors related to prior treatments.
  • Pacemaker Rhythm: Patients with a pacemaker rhythm are excluded from the study.
  • This exclusion criterion ensures that participants do not have devices that may interfere with the accurate recording and interpretation of ECG data using smartphone-based portable ECG devices.

结局指标

主要结局

The primary outcome measure is the correlation between ECG recordings obtained via smartphone-based portable ECG devices and the findings of coronary angiography.

时间窗: 6 Months

次要结局

  • Secondary outcomes may include clinical outcomes (e.g., mortality rates, major adverse cardiac events), patient perspectives, and the influence of patient characteristics and confounding factors on ECG accuracy.

研究者

发起方
Sunfox Technologies Private Limited
申办方类型
Other [Medical Device Manufacturer]
责任方
Principal Investigator
主要研究者

Chandra Mohan Belwal

Himalayan Institute of Medical Sciences

研究点 (1)

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