Artificial Intelligence to StrategiCally Enhance Pulmonary Embolism Response Team Activation

Pulmonary Embolism Subacute Massive Clinical Trial

— ASCENT  

Official title:

The Impact of System Wide Pulmonary Embolism Screening Program on PERT Activation, Utilization of Advanced Therapies, and 90-Day Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246045
• Other study ID #: STUDY20220475
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Jun Li, MD
• Phone: 440-882-0075
• Email: jun.li[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Pulmonary Embolism Subacute Massive

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Inari Medical

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-activation	Activation of PERT from time of CT scan to call; compared to historical control	3 days
Secondary	Length of stay	Total length of hospital stay	30 days
Secondary	6-minute walk test (6MWT)	The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.	6 minutes
Secondary	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