DIGIPREDICT-Physio-DE

Biomarkers Clinical Trial

Official title:

Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Evaluation of Physiological Sensors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05886569
• Other study ID #: DIGIPREDICT-Physio-DE
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: November 24, 2023

Study information

• Verified date: May 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate short-term physiological and biochemical inflammatory and cardiocirculatory biomarker kinetics in heart failure patients, using the DIGIPREDICT Physiopatch device - an investigational device that allows non-invasive realtime single-lead ECG registration and bioimpedance measurement as well as spotcheck photoplethysmography -, and standard laboratory methods, respectively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of heart failure, defined as: symptoms and signs of heart failure, elevated baseline NT-proBNP levels (>125pg/ml in sinus rhythm, >365 pg/ml in atrial fibrillation) without severe kidney disease (defined as eGFR(MDRD)<30 ml/min/1.73m²), and structural and/or functional abnormalities (according to 2021 ESC Heart Failure Guidelines)

• At least 2 days of further treatment on a DHZC intensive care unit (H3i, IPS1, IPS2) or intermediate care unit (H3 - heart failure unit) expected at enrolment.

• Age of subject is = 18years.

• Subject is female, male, divers.

• Signed written informed consent.

• For female subject or divers subject:

1. Negative highly sensitive urine or serum pregnancy test before inclusion, and

2. Practicing a highly effective birth control method (failure rate of less than 1%):

1. combined (estrogen and progestogen containing) hormonal

2. contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or

3. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or

4. intrauterine device (IUD), or

5. intrauterine hormone-releasing system ( IUS), or

6. bilateral tubal occlusion, or

7. vasectomised partner, or

8. heterosexual abstinence.

Exclusion Criteria:

• Subject is breastfeeding.

• Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.

• Subject is treated with immunosuppressive drugs at enrolment.

• Subject requires mechanical circulatory support at enrolment (IABP, veno-arterial ECMO, Impella, VAD, TAH).

• Subject requires extracorporeal lung support at enrolment (veno-venous ECMO, interventional lung assist).

• Subject requires invasive ventilation at enrolment.

• Subject requires renal replacement therapy.

• Subjects with an active stimulation device (implanted or not) (e.g. pacemaker, nerve stimulator).

• Subject has a known colonisation or infection with multi-drug-resistant pathogens.

• Subject suffers from a skin disease at all possible placement sites for the DIGIPREDICT Physiopatch.

Subject has damaged skin at all fingertips.

• Subject has highly sensitive skin to (medical) adhesives.

• Subject shows an inability to comply with all of the study procedures and follow-up visits.

• Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.

• Subject is legally detained in an official institution.

• Subject is dependent on the sponsor, the investigator or the study sites.

• Subject participates in another clinical investigation according to MPDG/MDR, or in a study according to AMG/CTR that investigates immunosuppressive drugs at the time of this study.

Related Conditions & MeSH terms

• Biomarkers

Intervention

Device:
• DIGIPREDICT Physiopatech
Application of the DIGIPREDICT Physiopatch investigational device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term kinetics of C-reactive protein	Outcome is the detection of kinetics of C-reactive protein values [mg/L] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of procalcitonin	Outcome is the detection of kinetics of procalcitonin values [ng/mL] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of interleukin-6	Outcome is the detection of kinetics of interleukin-6 values [ng/L] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of ferritin	Outcome is the detection of kinetics of ferritin values [µg/L] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of NT-pro brain natriuretic peptide	Outcome is the detection of kinetics of NT-pro brain natriuretic peptide [ng/L] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of high sensitive troponin T	Outcome is the detection of kinetics of high sensitive troponin T [ng/L] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of lactate	Outcome is the detection of kinetics of lactate [mg/dL] between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of blood pH	Outcome is the detection of kinetics of blood pH between at least two timestamps.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of body surface temperature	Outcome is the detection of kinetics of body surface temperature [°C] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Primary	Short-term kinetics of bioimpedance	Outcome is the detection of kinetics of bioimpedance [Ohm] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis.; Short-term is defined as <= 26hours; biomarker kinetics are defined as >20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.	4 days
Secondary	Correlation between C-reactive protein and body surface temperature	Outcome is the detection of a correlation between C-reactive protein [mg/L] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between C-reactive protein and bioimpedance	Outcome is the detection of a correlation between C-reactive protein [mg/L] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between procalcitonin and body surface temperature	Outcome is the detection of a correlation between procalcitonin [ng/mL] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between procalcitonin and bioimpedance	Outcome is the detection of a correlation between procalcitonin [ng/mL] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between interleukin-6 and body surface temperature	Outcome is the detection of a correlation between interleukin-6 [ng/L] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between interleukin-6 and bioimpedance	Outcome is the detection of a correlation between interleukin-6 [ng/L] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between ferritin and body surface temperature	Outcome is the detection of a correlation between ferritin [µg/L] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between ferritin and bioimpedance	Outcome is the detection of a correlation between ferritin [µg/L] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between NT-pro brain natriuretic peptide and body surface temperature	Outcome is the detection of a correlation between NT-pro brain natriuretic peptide [ng/L] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between NT-pro brain natriuretic peptide and bioimpedance	Outcome is the detection of a correlation between NT-pro brain natriuretic peptide [ng/L] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between high sensitive troponin T and body surface temperature	Outcome is the detection of a correlation high sensitive troponin T [ng/L] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between high sensitive troponin T and bioimpedance	Outcome is the detection of a correlation high sensitive troponin T [ng/L] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between lactate and body surface temperature	Outcome is the detection of a correlation between lactate [mg/dL] and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between lactate and bioimpedance	Outcome is the detection of a correlation between lactate [mg/dL] and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between blood pH and body surface temperature	Outcome is the detection of a correlation between blood pH and body surface temperature [°C].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days
Secondary	Correlation between blood pH and bioimpedance	Outcome is the detection of a correlation between blood pH and bioimpedance [Ohm].; Correlations between physiological biomarkers and biochemical biomarkers will be analysed graphically and by Spearman's correlation coefficient.	4 days