Low Ejection Fraction in Single Lead ECG
Detection of Reduced Left Ventricular Ejection Fraction and Atrial Arrhythmias With Single Lead ECG Using Artificial Intelligence
1 other identifier
observational
1,935
1 country
2
Brief Summary
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left ventricular EF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2022
CompletedDecember 9, 2022
December 1, 2022
12 months
August 11, 2021
December 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Single-lead ECG based algorithm development
Evaluate performance of single-lead ECG based algorithm to identify individuals with reduced ejection fraction.
Within two minutes of device use
Interventions
Auscultation of heart sounds using electronic stethoscope
Eligibility Criteria
Patients undergoing a transthoracic echocardiogram will be enrolled. Patients who are over the age of 60 or who are at risk for heart failure (hypertension, murmur, etc.) will be targeted for enrollment. We will also target patients with a referral diagnosis of dyspnea on exertion, orthopnea, lower extremity edema, and possible heart failure.
You may qualify if:
- English-speaking adults who are 18 years and older
- Able and willing to provide informed consent
- Complete a clinical echocardiogram within 7 days before or after study procedures
You may not qualify if:
- Unwilling or unable to provide informed consent
- Patients who are hospitalized
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Prairie Cardiovascular Consultants
O'Fallon, Illinois, 62269, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Marrus, MD
Prairie Cardiovascular
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 18, 2021
Study Start
June 1, 2021
Primary Completion
May 24, 2022
Study Completion
May 24, 2022
Last Updated
December 9, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share