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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Primary Endpoint
- Short-term kinetics of high sensitive troponin T
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Negative highly sensitive urine or serum pregnancy test before inclusion, and
- •Practicing a highly effective birth control method (failure rate of less than 1%):
- •combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
- •progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
- •intrauterine device (IUD), or
- •intrauterine hormone-releasing system ( IUS), or
- •bilateral tubal occlusion, or
- •vasectomised partner, or
- •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.
Outcomes
Primary Outcomes
Short-term kinetics of high sensitive troponin T
Time Frame: 4 days
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.
Short-term kinetics of lactate
Time Frame: 4 days
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.
Short-term kinetics of C-reactive protein
Time Frame: 4 days
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.
Short-term kinetics of interleukin-6
Time Frame: 4 days
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.
Short-term kinetics of ferritin
Time Frame: 4 days
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.
Short-term kinetics of blood pH
Time Frame: 4 days
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.
Short-term kinetics of bioimpedance
Time Frame: 4 days
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.
Short-term kinetics of procalcitonin
Time Frame: 4 days
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.
Short-term kinetics of body surface temperature
Time Frame: 4 days
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.
Short-term kinetics of NT-pro brain natriuretic peptide
Time Frame: 4 days
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.
Secondary Outcomes
- Correlation between NT-pro brain natriuretic peptide and body surface temperature(4 days)
- Correlation between lactate and body surface temperature(4 days)
- Correlation between blood pH and body surface temperature(4 days)
- Correlation between C-reactive protein and bioimpedance(4 days)
- Correlation between interleukin-6 and bioimpedance(4 days)
- Correlation between ferritin and body surface temperature(4 days)
- Correlation between lactate and bioimpedance(4 days)
- Correlation between blood pH and bioimpedance(4 days)
- Correlation between procalcitonin and body surface temperature(4 days)
- Correlation between interleukin-6 and body surface temperature(4 days)
- Correlation between ferritin and bioimpedance(4 days)
- Correlation between C-reactive protein and body surface temperature(4 days)
- Correlation between procalcitonin and bioimpedance(4 days)
- Correlation between NT-pro brain natriuretic peptide and bioimpedance(4 days)
- Correlation between high sensitive troponin T and body surface temperature(4 days)
- Correlation between high sensitive troponin T and bioimpedance(4 days)
Investigators
Laurenz Kopp Fernandes
Senior physician, Transplant Outpatient Unit
Charite University, Berlin, Germany