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IRB Closed
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| Name | Class |
|---|---|
| Inari Medical | INDUSTRY |
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Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas.
The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation.
The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-Invasive Strategy | Experimental | Patients who do not clearly qualify for early intervention (including catheter-directed therapies, systemic thrombolysis, or invasive hemodynamic support) based on assessment by PERT members, will undergo walk testing on the first day of admission. If the subject meets criteria based on pre-specified hemodynamic changes, then the patient will be randomized in a 2:1 fashion to early invasive strategy with catheter-directed therapies as treatment arm. |
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| Traditional Medical Therapy | Active Comparator | Patients who do not clearly qualify for early intervention (including catheter-directed therapies, systemic thrombolysis, or invasive hemodynamic support) based on assessment by PERT members, will undergo walk testing on the first day of admission. If the subject meets criteria based on pre-specified hemodynamic changes, then the patient will be randomized (2:1, treatment to control) to traditional routine care with medical therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking test | Diagnostic Test | PERT will be activated by AI algorithm. As a result of the discussion, patients will either be determined to be appropriate for immediate invasive strategy versus watchful waiting depending on whether high-risk PE criteria are met. For those in the intermediate-high risk category, there remains ambiguity on timing and appropriateness of invasive intervention. On day 1 of admission, patients will undergo a walking test evaluating for abnormalities in heart rate, heart rate recovery, and oxygen need. If criteria is met, patients will be randomized in a 2:1 fashion (treatment versus control) to evaluate use of early-invasive strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-activation | Activation of PERT from time of CT scan to call; compared to historical control | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Total length of hospital stay | 30 days |
| 6-minute walk test (6MWT) | The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Li, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44416 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33570502 | Background | Lacey MJ, Hammad TA, Parikh M, Tefera L, Sharma P, Kahl R, Zemko A, Li J, Carman T, Schilz R, Shishehbor MH. Prospective Experience of Pulmonary Embolism Management and Outcomes. J Invasive Cardiol. 2021 Mar;33(3):E173-E180. Epub 2021 Feb 11. | |
| 33844438 | Background | Parikh M, Chahine NM, Hammad TA, Tefera L, Li J, Carman T, Schilz R, Shishehbor MH. Predictors and potential advantages of PERT and advanced therapy use in acute pulmonary embolism. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1430-1437. doi: 10.1002/ccd.29697. Epub 2021 Apr 12. |
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| 6 minutes |
| Change in quality of life as measured by PEmb QoL | PEmb-QoL summary score (0-100, higher score indicate worse outcome) | Baseline, 30 days, 90 days |