- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05171595
Real Time ST-segment Deviation Detection in High-risk Patients Detected by Wireless Single-lead ECG
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Copenhagen, Dánsko, 2100
- Rigshospitalet, Department of Anesthesiology, Centre for Cancer and Organ Diseases, University of Copenhagen, Blegdamsvej 9, 2200 Copenhagen, Denmark
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
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
WARD-Surgery:
- ≥ 60 years
- Elective major abdominal cancer surgery
- Estimated surgical duration ≥ 2 hours.
Exclusion Criteria:
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
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
no myocardial injury
In 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.
|
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.
Another monitoring device in the study was the plasma concentration of high-sensitive cardiac troponin T (hsTnT).
|
|
Myocardial injury
In 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.
|
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.
Another monitoring device in the study was the plasma concentration of high-sensitive cardiac troponin T (hsTnT).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG
Časové okno: 30 minutes
|
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.
|
30 minutes
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 1 minute.
Časové okno: 1 minute
|
1 minute
|
|
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 10 minutes.
Časové okno: 10 minutes
|
10 minutes
|
|
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 20 minutes.
Časové okno: 20 minutes
|
20 minutes
|
|
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 30 minutes.
Časové okno: 30 minutes
|
30 minutes
|
|
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 1 minute.
Časové okno: 1 minute
|
1 minute
|
|
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 10 minutes.
Časové okno: 10 minutes
|
10 minutes
|
|
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 20 minutes.
Časové okno: 20 minutes
|
20 minutes
|
|
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.
Časové okno: 3 days
|
3 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ST-Deviation WARD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .