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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 days, 90 days

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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