Novel On-body Evaluation of Cardiac Health for Oncology

Part of paid clinical trials in Golden, Colorado.

Sponsor
Skribe Medical
Study ID
NCT07158450
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.

Key Dates

Start date
Oct 9, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Healthy
    No known or suspected cardiac disease
  • Arm: Borderline LVEF
    Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction
  • Arm: Reduced LVEF
    Known diagnosis of reduced left ventricular ejection fraction

Primary Outcome Measure

Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates [ Time Frame: From baseline through study completion (up to 6 months) at each paired assessment ]

Locations (7)

FacilityCityStateZIPSite coordinators
Colorado Heart and VascularGoldenColorado80401-
Clearwater Cardiovascular ConsultantsClearwaterFlorida33756-
Midwest Cardiovascular InstituteNapervilleIllinois60540-
Cardiovascular Institute of the SouthHoumaLouisiana70360-
Strong Memorial HospitalRochesterNew York14642-
Cardiology Consultants of PhiladelphiaYardleyPennsylvania19067-
Stern Cardiovascular CenterGermantownTennessee38138-

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