Non-invasive Pulmonary Artery Prediction (ADOPTS)
ADOPTS
Feasibility Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects
1 other identifier
observational
25
1 country
1
Brief Summary
A proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (PAP), a physiologic marker of cardiopulmonary function. The algorithm was developed from PAP recordings obtained during invasive right heart catheterization. The study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records EKG, heart sounds, and thoracic impedance has yet to be established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedDecember 20, 2022
November 1, 2022
5 months
November 29, 2022
December 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Outcome
The primary outcome of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous PAP measurement obtained during right heart catheterization.
the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes
Study Arms (1)
right heart catheterization cohort
The study investigators will screen up to 50 Veterans undergoing right heart catheterization for clinical indications with the intention to consent up to 20 Veterans. Veterans will be screened by study investigators. Veterans who decline to consent and vulnerable populations (pregnant, incapacitated, incarcerated) will be excluded from the study.
Interventions
Connect to a heart monitor to record heart rate, blood pressure and blood oxygen levels Place sterile sheets on chest and neck (or groin area) Clean the skin over the neck or groin Give local anaesthetic to numb the area (this may sting a little when it is given) Gently pass a catheter into a vein to the heart Record pressure readings from the heart chambers and lungs Give medication, depending on heart's pressure readings Remove the catheter and apply pressure where it was inserted
Eligibility Criteria
The study investigators will screen up to 50 Veterans undergoing right heart catheterization for clinical indications with the intention to consent up to 20 Veterans. Veterans will be screened by study investigators. Veterans who decline to consent and vulnerable populations (pregnant, incapacitated, incarcerated) will be excluded from the study.
You may qualify if:
- Written informed consent and authorization to use and disclose health information.
- years of age or older.
- Diagnosis of HF for \>3 months, with preserved or reduced left ventricular ejection fraction (LVEF).
- Female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial.
You may not qualify if:
- Active infection.
- Unable to tolerate a right heart catheterization (RHC), in the investigator's opinion.
- Implantation of cardiac resynchronization therapy (CRT)\<3 months before enrollment.
- Enrolled in concurrent studies that may confound the results of this study.
- Clinical condition that would not allow them to complete the study, in the investigator's opinion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Silverleaf Medical Sciences INClead
- VA Loma Linda Health Care Systemcollaborator
Study Sites (1)
Loma Linda Veterans Administration Healthcare System
Loma Linda, California, 92357, United States
Related Publications (1)
Zheng J, Abudayyeh I, Mladenov G, Struppa D, Fu G, Chu H, Rakovski C. An artificial intelligence-based noninvasive solution to estimate pulmonary artery pressure. Front Cardiovasc Med. 2022 Aug 24;9:855356. doi: 10.3389/fcvm.2022.855356. eCollection 2022.
PMID: 36093166RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Patel
Loma Linda Veterans Administration Healthcare System
- STUDY DIRECTOR
Islam Abudayyeh
Silverleaf Medical Sciences INC
- STUDY CHAIR
Jianwei Zheng, Ph.D.
Silverleaf Medical Sciences INC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2022
First Posted
December 8, 2022
Study Start
February 1, 2023
Primary Completion
July 1, 2023
Study Completion
October 1, 2023
Last Updated
December 20, 2022
Record last verified: 2022-11