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Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial

A Pilot Single-center Randomized Controlled Trial of Software Guided Point-of-care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 Investogators will harness the power of a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device that can generate an accurate estimate of left ventricular ejection fraction in \<5 minutes by medical assistants (MA) with minimal training at a single Corewell Health outpatient practice."
  • "Point of care ultrasound (POCUS) is an adaptation of formal ultrasound technology used to evaluate cardiac structure and function known as transthoracic echocardiography (TTE)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether ultrasound done during a clinic visit is practical for checking for heart failure. It compares ultrasound with usual care to help plan a larger study. It is for adults with new heart-related symptoms or a first heart clinic visit at a participating Corewell Health clinic, and staff at those clinics.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients: Age 18 or older when agreeing to join.
  • Patients: Visit a participating Corewell Health study clinic.
  • Patients: See a primary care provider for new heart-related symptoms, such as trouble breathing during activity or when lying down, or have a new-patient heart clinic visit.
  • Patients: Weigh at least 40 kilograms (about 88 pounds).
  • Staff: Age 18 or older when giving spoken agreement to join.
  • Staff: Work at a Corewell Health clinic where patients will be enrolled.

Who can't join

  • Patients: Have a recorded echocardiogram (heart ultrasound) within the past 3 years.
  • Patients: Have had heart surgery or were born with heart disease.
  • Patients: Have lung disease that requires oxygen.
  • Patients: Have a body mass index (BMI), a measure based on height and weight, of 40 or higher.
  • Patients: Are pregnant.
  • Patients: Are not native English speakers and cannot understand spoken or written English well enough to agree to join or complete surveys in English.
  • Patients: Have problems with thinking or memory and have a legal representative or guardian.
  • Staff: The lead researcher decides they are not suitable or eligible for any reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Patient Inclusion/Exclusion Criteria Inclusion Criteria: * 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 Exclusion Criteria: * 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 Inclusion/Exclusion Criteria Inclusion: * 18 years of age or older at time of verbal consent * Employed to work at a CH clinic where patient enrollment is planned Exclusion: * Deemed inappropriate or ineligible for any reason at PI discretion

Study sites (1)

MI