Artificial Intelligence for Pulmonary Embolism

(ASCENT Trial)

Overseen By Jun Li, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Age <18, Pregnancy, Unable to walk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jun Li, MD

Principal Investigator

University Hospitals

Eligibility Criteria

This trial is for patients with pulmonary embolism, a condition where blood clots block the lungs' arteries. It's designed to help those who might benefit from quick and aggressive treatment. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have a lung clot and heart strain shown in a CT scan, with either high heart rate, fast breathing, low blood pressure, or low oxygen levels.

My doctor thinks I should consider enzyme replacement therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Active Phase

Participants undergo randomization to early-invasive strategy or traditional medical therapy, including walk testing and assessment by PERT

30 days

Daily visits during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

90 days

Visits at 30 days and 90 days

Treatment Details

Interventions

• Aidoc

Trial Overview The study tests an AI program called Aidoc that decides which patients need urgent care for their pulmonary embolism. It compares outcomes of patients selected by AI for immediate action versus traditional methods.

Participant Groups

Group I: Early-Invasive Strategy Experimental Treatment 1 Intervention

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 II: Traditional Medical Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Inari Medical

Industry Sponsor

Trials

18

Recruited

5,300+