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Artificial Intelligence

Artificial Intelligence for Pulmonary Embolism (ASCENT Trial)

N/A
Waitlist Available
Led By Jun Li, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 90 days
Awards & highlights

Summary

This trial aims to study the use of an artificial intelligence program to identify patients at high risk of pulmonary embolism. The goal is to determine if this AI program can help in deciding which patients need

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves decision-making rather than medication, there are no direct side effects from interventions like drugs or surgery. However, indirect effects may arise from any subsequent treatments chosen as a result of the AI recommendations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time-to-activation
Secondary study objectives
6-minute walk test (6MWT)
Change in quality of life as measured by PEmb QoL
Length of stay

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early-Invasive StrategyExperimental Treatment1 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 TherapyActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Walking test
2016
N/A
~200

Find a Location

Who is running the clinical trial?

Inari MedicalIndustry Sponsor
14 Previous Clinical Trials
4,521 Total Patients Enrolled
9 Trials studying Pulmonary Embolism
3,551 Patients Enrolled for Pulmonary Embolism
University Hospitals Cleveland Medical CenterLead Sponsor
320 Previous Clinical Trials
339,598 Total Patients Enrolled
Jun Li, MDPrincipal InvestigatorUniversity Hospitals
13 Previous Clinical Trials
1,523 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
120 Patients Enrolled for Pulmonary Embolism
~260 spots leftby Jan 2026
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