Artificial Intelligence to StrategiCally Enhance Pulmonary Embolism Response Team Activation

NCT ID: NCT06246045

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-01-01

Brief Summary

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.

Conditions

Pulmonary Embolism Subacute Massive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early-Invasive Strategy

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.

Group Type: EXPERIMENTAL

Walking test

Intervention Type: 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.

Traditional Medical Therapy

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.

Group Type: ACTIVE_COMPARATOR

Walking test

Intervention Type: 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.

Interventions

Walking 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients obtaining a CT at University Hospitals found to have a pulmonary embolism with evidence of right ventricular strain (RV:LV > 0.9) along with an abnormal vital sign (HR > 110 bpm, RR > 30/min, SBP < 100 mmHg, or O2 saturation < 90%)
• Patients undergoing PERT discussion as deemed appropriate by the provider

Exclusion Criteria

• Age <18
• Pregnant patients. Women of childbearing age will be asked if they are pregnant before enrollment. No formal pregnancy test will be performed as a part of this study. If a patient does require invasive intervention, as part of the routine procedure for cardiac catheterization laboratory, women of childbearing age will either undergo pregnancy testing or opt-out per their own discretion
• Patients unable to perform 6MWT (e.g., lack of one or both legs) will not be included in the randomization. They will be included in the observation for routine treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inari Medical

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Li, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33570502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33844438 (View on PubMed)

Other Identifiers

STUDY20220475

Identifier Type: -

Identifier Source: org_study_id