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| Name | Class |
|---|---|
| PIH Health Good Samaritan Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheterization | Device | 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. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with heart failure conditions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwei Zheng, Ph.D. | Contact | 9493298388 | zheng@slmedsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianwei Zheng, Ph.D. | Silverleaf Medical Sciences | Study Chair |
| Ihab Alomari, Dr. | PIH Good Samaritan Hospital | Principal Investigator |
| Islam Abudayyeh, Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PIH Good Samaritan Hospital | Recruiting | Los Angeles | California | 90017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36093166 | Result | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Loma Linda University Health |
| Study Director |
| D012140 |
| Respiratory Tract Diseases |