An observational study in Cardiogenic Shock, Acute Myocardial Infarction and Acute Decompensated Heart Failure, sponsored by NIRSense Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by NIRSense Inc. · Observational
Among 49 studies in Shock, Cardiogenic with a site in United States — 19 open to participants now, 22 under way, none of them phase 3. Shock, Cardiogenic · United States.
Among the 49 studies in Shock, Cardiogenic with a site in United States, this one is the 20th largest by planned enrollment of the 24 observational ones, is one of 4 that started in 2025, is one of 24 observational ones, reaches primary completion later than 6 of the 21 other live ones, and was the 49th registered.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 155 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →19 of the 49 studies in Shock, Cardiogenic with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 102 Shock, Cardiogenic studies recruiting now, 70 (69%) set no upper age limit and 9 (9%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →49 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2025.
Median enrollment 30 across the 25 interventional studies, 137 across the 24 observational. Of the 20 that completed or were terminated, 6 (30%) have results posted.
13 of 49 have an industry lead sponsor. The 10 most frequent:
NIRSense Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
NIRSense Inc. has 1 study filed under Shock, Cardiogenic — fewer than ten, so there is no comparison to draw.
10 of the studies in Shock, Cardiogenic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05267886Ottawa Heart Institute Research CorporationCAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock | 2026-12 |
| NCT05800951Henry Ford Health SystemCan Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock | 2026-12-31 |
| NCT06253104Tufts Medical CenterChanges in Skeletal Muscle Thickness in Patients With Acute Heart Failure | 2026-12-31 |
| NCT07402018Thomas Jefferson UniversityIntra-aortic Balloon Counterpulsation (IABC) Compliance | 2026-12-31 |
| NCT07825363NIRSense Inc.Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock | 2027-01 |
Among the 49 studies in Shock, Cardiogenic with a site in United States, from their registry updates:
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and photoplethysmography (PPG), combined with an electrocardiography/impedance cardiography (ECG/ICG) sensor, to continuously monitor tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, stroke volume, and related metrics. Up to 20 adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction or acute decompensated heart failure and in Society for Cardiovascular Angiography and Interventions (SCAI) shock stage B, C, or D will wear the sensors on the sternum, forearm, and other locations for approximately 24 to 72 hours during standard care. Sensor data will be compared with standard-of-care hemodynamic and laboratory measurements and with the patient's clinical course to evaluate the feasibility of the device, the correlation of its measurements with established clinical parameters, and its potential to detect deterioration in SCAI shock stage earlier. No treatment decisions are made based on the study device.
Background: Cardiogenic shock (CS) carries a poor prognosis and is the leading cause of death in patients with acute myocardial infarction. When decompensation occurs there is an imperative to institute treatment rapidly. Standard intensive care unit monitoring relies on intermittent hemodynamic and laboratory measures. Continuous, noninvasive measurement of tissue perfusion and oxygenation could allow earlier recognition of deterioration and earlier intervention.
Device: The NIRSense Tissue Oximetry Sensor System is an investigational, non-significant-risk, noninvasive wearable optical physiological monitoring system. It consists of a sensor patch with multiple red and near-infrared light sources and detectors (NIRS and PPG), a pre-applied medical-grade adhesive, an ECG/ICG sensor patch, and a display unit (tablet running the NIRSense application) that receives data over Bluetooth and stores it. The sensor estimates StO2 in microvascular tissue up to about 2.5 cm below the skin and derives PPG-based metrics including pulse rate, respiratory rate, and perfusion index. The device has not been cleared or approved by the U.S. FDA.
Design: Prospective data collection, single-center observational study. Two populations are targeted: (1) patients with acute myocardial infarction, with or without shock (SCAI B to D), admitted for coronary angiography and subsequent interventions, and (2) patients with acute decompensated heart failure admitted for pulmonary artery catheter insertion and subsequent interventions. Participants are enrolled from the existing Cleveland Clinic Florida patient population in a way that avoids disruption of clinical workflow. After informed consent, sensors are placed on the sternum, forearm, and other locations according to manufacturer specifications and remain in place while the patient is in the cardiac intensive care unit, for approximately 24 to 72 hours. Sensors may be repositioned during catheterization or imaging at the investigator's discretion. Participation is limited to the single standard-of-care admission; there is no study follow-up visit or call.
Data collected: Continuous sensor data (StO2, SpO2, pulse rate, respiratory rate, ECG/ICG-derived stroke volume, PPG-derived metrics) and sensor placement images. Data collected during standard-of-care treatment and shared with the sponsor: demographics, Fitzpatrick skin type, medical history, concomitant medications, physical examination, vital signs, a single 12-lead ECG, blood pressure, heart rate, cardiac output (thermodilution) where obtained, clinically ordered lactate values, SCAI stage, and clinical course. Adverse events and device deficiencies are recorded from enrollment through sensor removal. Clinical staff complete a usability survey after using the device on 5 patients.
Analysis: Descriptive statistics for demographics and baseline characteristics; adverse events summarized by frequency and percentage, severity, and device relatedness. Effectiveness analyses use all evaluable data and compare device measurements with standard-of-care hemodynamic parameters and with SCAI stage trajectory, as specified in the Statistical Analysis Plan. Following an interim analysis of the 20-patient pilot, enrollment may be expanded to 200 patients under a protocol amendment; that expansion is not part of this record.
Adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction undergoing coronary angiography, or with acutely decompensated heart failure, who are in SCAI shock stage B, C, or D. Participants are recruited from the existing patient population of the recruitment site.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute myocardial infarction, with or without shock (SCAI stage B to D), admitted for coronary angiography and subsequent interventions. Enrolled at the time of consent for coronary angiography.
Device: NIRSense Tissue Oximetry Sensor System
Patients with acute decompensated heart failure (SCAI stage B to D) admitted for pulmonary artery catheter insertion and subsequent interventions. Consented before or after catheterization.
Device: NIRSense Tissue Oximetry Sensor System
Investigational noninvasive wearable sensor patches using near-infrared spectroscopy and photoplethysmography to continuously measure tissue oxygen saturation, SpO2, pulse rate, respiratory rate, and perfusion index, plus an ECG/ICG sensor patch for stroke volume, with a tablet display and recording application. Sensors are applied to the sternum, forearm, and other locations with a medical-grade adhesive and worn for approximately 24 to 72 hours during standard cardiac ICU care. Sensor data are collected for research only and are not used for treatment decisions.
Also known as: Envello Core, NIRSense Sensor Oximetry System patch
Correlation between NIRSense sensor measurements and standard-of-care hemodynamic parameters
Correlation coefficients (Pearson and Spearman) between time-matched NIRSense measurements (tissue oxygen saturation, perfusion index, SpO2, pulse rate, respiratory rate, ICG-derived stroke volume) and standard-of-care clinical measurements (arterial blood pressure, heart rate, pulmonary artery and central venous pressures where a pulmonary artery catheter is present, cardiac output by thermodilution, and lactate).
Time frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
Feasibility: proportion of intended monitoring time with valid sensor data
Percentage of the intended monitoring period during which each sensor provided valid StO2 and PPG data, per sensor site, including data recovered from onboard memory after wireless transmission gaps.
Time frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
Patient tolerance: device-related adverse events and device deficiencies
Number and percentage of participants with adverse events, adverse device effects (including skin irritation or redness at the adhesive site), and device deficiencies, and number of participants requesting early sensor removal.
Time frame: From enrollment through sensor removal, approximately 24 to 72 hours
Association between NIRSense measurement trends and change in SCAI shock stage
Change in NIRSense measurements (StO2, StO2 variability, perfusion index, stroke volume) relative to the time of clinically documented change in SCAI shock stage, including the lead time between the first sustained change in device metrics and the clinically recognized deterioration.
Time frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
Distribution of NIRSense measurements by SCAI shock stage
Summary statistics of StO2, perfusion index, and ICG-derived stroke volume at each sensor site by SCAI shock stage (B, C, D, E), to inform development of a predictive model of shock status.
Time frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
Clinical staff usability feedback
Responses to a paper survey completed by study staff (principal investigator, nurses, residents, and others involved in the study) on their experience using the sensor system.
Time frame: After the device has been used on 5 patients (approximately 1 to 6 months after first enrollment)
Plan to share: Undecided
Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 19 months after the start.
Of 84 observational studies under Shock, Cardiogenic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24. This study's planned 19 months is below that.
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NIRSense Inc.