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Real Time ST-segment Deviation Detection in High-risk Patients Detected by Wireless Single-lead ECG

NCT05171595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 698

Last updated 2022-01-12

No results posted yet for this study

Summary

This study primarily aims to describe the frequency of significant ST-deviations, defined as ECG-ST-deviations \<-0.255 or \>0.245 mV for a minimum duration of 30 minutes as measured by a single-lead ECG in patients admitted with AECOPD or following major abdominal surgery. Secondarily we will describe the frequency of ST-deviations \<-0.255 or \>0.245 mV for a minimum duration of 1, 10 and 20 minutes, respectively, as well as for patients with ST-deviations \<-0.1 or \>0.1 mV for a minimum duration of 1, 10, 20 and 30 minutes, respectively. Lastly, we will investigate the association between ST-deviations and subsequent myocardial injury while adjusting for known risk factors.

Conditions

  • Myocardial Injury

Interventions

DEVICE

Lifetouch single-lead ECG monitoring

The continuous wireless monitoring is a single-lead ECG patch (Isansys Life Touch patch) which consists of two ECG electrodes placed on the left side of the patients' thorax. The patch measures respiratory rate (RR), heart rate (HR), heart rate variability (HRV) and electrocardiogram (ECG)s.

DIAGNOSTIC_TEST

high-sensitive TnT measurements

Another monitoring device in the study was the plasma concentration of high-sensitive cardiac troponin T (hsTnT).

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2020-06-09
Completion
2020-06-09
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171595 on ClinicalTrials.gov