Non-invasive Pulmonary Artery Prediction (ADOPTS)

Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects

Cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. Implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. The CardioMEMs System, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous PAP measurement. However, there are no commercially available wearable systems that can reproduce continuous PAP tracings.

This study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating EKG, heart sounds, and thoracic impedance can reproduce a continuous PAP tracing obtained during right heart catheterization.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: catheterization

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Jianwei Zheng, Ph.D.; Phone Number: 9493298388; Email: zheng@slmedsci.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • Recruiting
      • PIH Good Samaritan Hospital
      • Contact: Ihab Alomari, Dr.; Phone Number: 505-573-1457

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with heart failure conditions.

Description

Inclusion Criteria:

1. Subjects age 18+ years
2. Undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or Swan-Ganz catheter.

Exclusion Criteria:

1. Vulnerable population
2. Unable to consent for any reason
3. Unstable patient
4. Known skin reaction to latex or adhesives

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Catheterization Arm; Participants will be limited to adults older than 18 years of age, able to consent, planned for the cardiac catheterization lab for a right heart catheterization or in the cardiac care unit with an existing arterial line or Swan-Ganz catheter actively measuring the pulmonary artery pressure on a continuous basis.	Device: catheterization; Swan-Ganz catheterization (also called right heart catheterization or pulmonary artery catheterization) is the passing of a thin tube (catheter) into the right side of the heart and the arteries leading to the lungs. It is done to monitor the heart's function and blood flow and pressures in and around the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of pulmonary artery pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	The primary objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission.	the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes.
The correlation of pulmonary artery wedge pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	The second objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery wedge pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission.	the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds).

Collaborators and Investigators

• Sponsor: Silverleaf Medical Sciences INC
• Collaborators: PIH Health Good Samaritan Hospital
• Investigators: Study Chair: Jianwei Zheng, Ph.D., Silverleaf Medical Sciences; Principal Investigator: Ihab Alomari, Dr., PIH Good Samaritan Hospital; Study Director: Islam Abudayyeh, Dr., Loma Linda University Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2022
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (ACTUAL): November 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension
• Other Study ID Numbers: ADOPTS_GOODSAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No