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Myocardial InjuryNCT05171595

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

An observational study of Myocardial Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Injury
What is being tested?
Lifetouch single-lead ECG monitoring and high-sensitive TnT measurements
Type of treatment
Medical device
How many people
698 participants
Where
1 siteDenmark
Study dates
20 Feb 2018to 9 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from the two WARD studies: WARD COPD and WARD Surgery. Patients were included at Rigshospitalet (department of abdominal surgery) and Bispebjerg Hospital (departments of emergency medicine, pulmonary medicine, and abdominal surgery) in Denmark from February 2018 to September 2020 after obtained written informed consent. Eligibility was determined by the investigator. All patients were monitored with wireless equipment, which continuously measures vital signs.

Who may be able to join

  • WARD-COPD:
  • ≥ 18 years
  • Patients admitted to emergency departments or pulmonary wards with AECOPD as admission diagnosis with suspected acute exacerbation of COPD
  • The diagnosis had to be sustained in the patient record at the time of inclusion
  • Expected admittance longer than 24 hours
  • Possibility of an investigator to include the patient within 24 hours from admission
Show all 10Show fewer
  • WARD-Surgery:
  • ≥ 60 years
  • Elective major abdominal cancer surgery
  • Estimated surgical duration ≥ 2 hours.

Who cannot join

  • WARD-COPD:
  • Patients who were not expected to cooperate to wear the monitoring equipment
  • Unable to give informed consent
  • Patients who were withheld active treatment
  • Implanted cardioverter defibrillator or pacemaker
  • Severe allergy for plaster/silicone
Show all 11Show fewer
  • WARD-Surgery:
  • Implanted cardioverter defibrillator or pacemaker
  • Allergy to study devices
  • Severe cognitive impairment assessed by MMSE
  • Inability to cooperate wearing the wireless monitoring equipment

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Rigshospitalet, Department of Anesthesiology, Centre for Cancer and Organ Diseases, University of Copenhagen, Blegdamsvej 9, 2200 Copenhagen, Denmark

    Copenhagen, 2100

Other trials in Denmark

About this study

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.

Read the detailed description

Background:

Assesment of wireless ECG-monitoring devices is essential for patient monitoring as it enables activity and out-of-hospital monitoring. Former studies have found a random variation for ST-deviations between wireless single-lead ECG and 12-lead ECG, which suggests that clinical monitoring of ST-deviations by single-lead ECG must be corrected for this to minimize false positive cases. Thus, we aimed to assess how a corrected limit of agreement for ST-deviations affects the ability to detect true myocardial ischemia by comparing thresholds to troponin elevations.

Methods:

This study sought to analyze data from two WARD cohort studies (NCT03491137) and (NCT03660501). Patients were included at Rigshospitalet and Bispebjerg Hospital from February 2018 to September 2020. The Surgery and COPD studies consisted of 505 and 202 patients, respectively, who were hospitalized with AECOPD or scheduled for elective major abdominal surgery lasting > 2 hours. All patients were monitored with wireless equipment, which continuously measured vital signs. The continuous wireless monitoring used in this study consisted of 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. Another monitoring device was the plasma concentration of high-sensitive cardiac troponin T (hsTnT, Cobas 8000, e801 module, Diagnostics Roche). In this study, patients were divided into a myocardial injury group with TnT elevations (of 20-64 ng/L with an absolute change of ≥ 5 ng/L, or a hsTnT level ≥65 ng/L, both evaluated as due to ischemic etiology) and a group with no myocardial injury.

Analysis:

Baseline characteristics of patients undergoing major abdominal surgery and patients admitted with AECOPD with and without myocardial injury will be summarized in frequency tables including Using descriptive statistics, we will describe the occurrence of ST-segment deviations in the single-lead (Lifetouch) ECG in patients with and without myocardial injury as well as the association between ST-deviation and subsequent myocardial injury, which will be adjusted for known risk factors; age, gender, BMI, daily smoker (never-, previous-, current smoker), alcohol consumption (none, below- or above recommendations), ASA classification (ASA 1,2,3,4), history of myocardial infarction, history of diabetes mellitus, history of chronic heart failure. Furthermore, the sensitivity and specificity of continuous wireless single-lead ECG with the applied threshold of <-0.255 mV and > 0.245 mV will be determined. Receiver operating characteristics (ROC) analyses will be made to determine which type of ST-deviation and which specific threshold value was most sensitive for TnT elevations. Through ROC analyses it will also be examined how different variations of durations affect the thresholds' sensitivity and specificity. Statistical analysis will be performed using statistical software SPSS.

Being tested
Lifetouch single-lead ECG monitoring, high-sensitive TnT measurements
Keywords
ST-deviations, Continuous wireless monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifetouch single-lead ECG monitoringDevice

    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.

  • high-sensitive TnT measurementsDiagnostic test

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

Study groups in NCT05171595
Study groupRoleWhat they receive
no myocardial injuryIn this study, patients were divided into groups of myocardial injury, where patients had TnT elevations (of 20-64 ng/L with an absolute change of ≥ 5 ng/L, or a hsTnT level ≥65 ng/L, both evaluated as due to ischemic etiology) and a group with no myocardial injury.
Receives: Device: Lifetouch single-lead ECG monitoring; Diagnostic Test: high-sensitive TnT measurements
Myocardial injuryIn this study, patients were divided into groups of myocardial injury, where patients had TnT elevations (of 20-64 ng/L with an absolute change of ≥ 5 ng/L, or a hsTnT level ≥65 ng/L, both evaluated as due to ischemic etiology) and a group with no myocardial injury.
Receives: Device: Lifetouch single-lead ECG monitoring; Diagnostic Test: high-sensitive TnT measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG

    The primary outcome is the frequency of patients with ST-deviation <-0.255 and/or >0.245 mV (0.1 mV + LoA) on single-lead ECG monitoring lasting ≥ 30 minutes.

    Measured: 30 minutes

Secondary outcomes (8)
  1. Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 1 minute.

    Measured: 1 minute

  2. Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 10 minutes.

    Measured: 10 minutes

  3. Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 20 minutes.

    Measured: 20 minutes

  4. Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 30 minutes.

    Measured: 30 minutes

  5. Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 1 minute.

    Measured: 1 minute

  6. Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 10 minutes.

    Measured: 10 minutes

  7. Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 20 minutes.

    Measured: 20 minutes

  8. Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 30 minutes and myocardial injury within three days of the first continuous monitoring day.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start20 Feb 2018
  3. Primary completion9 Jun 2020
  4. Study completion9 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171595
Sponsor's protocol ID
ST-Deviation WARD
Status last verified
Jan 2022
First submitted
10 Dec 2021
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.

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Clinical Trial NCT05171595 | AzTrials