What this study is
The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. The study aims to demonstrate feasibility of the procedure utilizing input from the patient, provider, and the clinic staff. Preliminary data will also be used to estimate the magnitude of effect in estimating sample size and power in participants who receive the POCUS procedure versus those who continue with standard of care. Up to 100 participants will be enrolled.
What's being tested
- Point of Care Ultrasound
Intervention · DEVICE
Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF
Study details
- Official title
- A Pilot Single-center Randomized Controlled Trial of Software Guided Point-of-care
- Sponsor
- Corewell Health West
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Enrolling
- 100 people
- Starts
- 2026-09-30
- Est. completion
- 2028-09-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedPatient
You may qualify if
- 18 years of age or older at time of consent
- Presenting to an enrolled CH study site with visit type:; A. PCP - New onset cardiac complaints (e.g., dyspnea on exertion, orthopnea, etc); B. Cardiology - New Patient
- Weight ≥ 40kg
You can't join if
- Documented echocardiogram in the past 3 years
- History of cardiac surgery or congenital heart disease
- O2-dependent pulmonary disease
- BMI ≥40kg/m2
- Pregnancy
- Non-native English speakers who have limited spoken or written understanding of the English language to be able to consent or complete surveys in English
- Cognitively impaired individuals with a legally authorized representative or guardian
Staff Participant
You may qualify if
- 18 years of age or older at time of verbal consent
- Employed to work at a CH clinic where patient enrollment is planned
You can't join if
- Deemed inappropriate or ineligible for any reason at PI discretion
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCorewell Health West
Grand Rapids, Michigan, United States
Study team
Sponsor
Corewell Health West
Study ID 2025-1219
Principal investigator
David McNamara, MD, MPh
Corewell Health West
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.