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| Name | Class |
|---|---|
| VA Loma Linda Health Care System | FED |
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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.
A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (EKG, heart sounds, and thoracic impedance) and from the PAP catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and Valsalva (1 minute recordings with 1-minute breaks). De-identified recordings from the prototype device will be shared with the team at Silverleaf Medical Science to derive a computed PAP. The investigators will test the hypothesis that computed PAP is no different than measured PAP. If the algorithm can produce a computed PAP with high accuracy,'[it would be the first wearable system to non-invasively report PAP.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| right heart catheterization | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwei Zheng, Ph.D. | Contact | 9492398388 | info@slmedsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Jay Patel | Loma Linda Veterans Administration Healthcare System | Principal Investigator |
| Islam Abudayyeh | Silverleaf Medical Sciences INC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Veterans Administration Healthcare System | Loma Linda | California | 92357 | 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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| Jianwei Zheng, Ph.D. |
| Silverleaf Medical Sciences INC |
| Study Chair |
| D012140 |
| Respiratory Tract Diseases |