Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04843371
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2021-04-08
Brief Title:
PPG to Predict Ejection Fraction and Other Echographic Data in the General Population
Sponsor:
Tulane University
Organization:
Tulane University
Study Overview
Official Title:
Photoplethysmography PPG to Predict Ejection Fraction and Other Echographic Data in the General Population
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are aiming to investigate the association between ejection fraction EF determined by echocardiography and signals obtained from Photoplethysmography PPG in the general population The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population
Finally the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as valvular heart disease structural heart diseases cardiomyopathies pericardial disease etc
Finally the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as valvular heart disease structural heart diseases cardiomyopathies pericardial disease etc
Detailed Description:
The investigators are proposing a cross-sectional cohort study where any individual 18 years old or older scheduled for an echocardiography at Tulane Universitys outpatient cardiology clinic can be included After consenting participants information on their demographics personal health habits medications and medical history will be collected via reviewing their electronic medical health records All participants will undergo an echocardiography as part of their routine medical care by their treating physician Important echocardiographic findings will be noted such as EF valvular heart disease pericardial disease cardiomyopathies and structural heart disease Additionally PPG recordings will be collected simultaneously while performing echography using the Biostrap wristband
The investigators will analyze the association between each echographic imaging feature and the PPG waveform obtained PPG waveform features will be used to develop a predictive model capable of calculating an estimate of ventricular ejection fraction without echocardiography All echocardiograms will be performed by experienced operators at Tulane Medical Center facilities The study will occur at a single study site Tulane Medical Center and clinics with appropriate facilities and equipment to conduct the study accurately and safely
An experienced echocardiogram technician or cardiology fellow will collect the PPG recordings using the Biostrap application De-identified echocardiogram reports including information on LVEF will be matched with the participants pulse report
The investigators will analyze the association between each echographic imaging feature and the PPG waveform obtained PPG waveform features will be used to develop a predictive model capable of calculating an estimate of ventricular ejection fraction without echocardiography All echocardiograms will be performed by experienced operators at Tulane Medical Center facilities The study will occur at a single study site Tulane Medical Center and clinics with appropriate facilities and equipment to conduct the study accurately and safely
An experienced echocardiogram technician or cardiology fellow will collect the PPG recordings using the Biostrap application De-identified echocardiogram reports including information on LVEF will be matched with the participants pulse report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None