Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center observational pilot study uses a wearable sensor system that combines near-infrared spectroscopy and photoplethysmography with ECG/ICG to continuously monitor tissue oxygen saturation and related metrics in adults with acute myocardial infarction or acute decompensated heart failure and SCAI shock stage B–D. Data from the sensor will be compared with standard care hemodynamic measurements and the patient’s clinical course to see if trends can signal deterioration earlier. Enrollment is up to 20 participants admitted to the cardiac ICU at Cleveland Clinic Florida and will last about 24 to 72 hours per participant during routine care. The device is investigational and non-significant-risk, and the study follows a prospective data-collection design without intervention. The goal is to assess feasibility and potential for earlier recognition of cardiogenic shock in a high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Acutely decompensated symptomatic heart failure (HF) documented by: (a) symptoms of HF requiring current treatment; (b) Society for Cardiovascular Angiography and Interventions (SCAI) stage B, C, or D; and (c) hospital admission with HF as the primary or secondary diagnosis; OR acute myocardial infarction (MI) patient undergoing coronary angiography
* Admitted to the intensive care unit and currently in SCAI stage B, C, or D
* Age 18 years or older
* Weight greater than 40 kg

Exclusion Criteria:

* Prior known severe allergy to medical-grade adhesive or tape (self-reported)
* Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational.
* The investigator believes the participant is not an appropriate candidate for the study

Where it's running

• Cleveland Clinic Florida, Weston Hospital
  Weston, Florida, United States Recruiting

Study contacts

• Principal investigator: David A. Baran, MD — Cleveland Clinic Florida
• Study coordinator: Thibault Roumengous, PhD
• Email: thibault@nirsense.com
• Phone: 804-625-1135

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.