- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246045
Artificial Intelligence to StrategiCally Enhance Pulmonary Embolism Response Team Activation (ASCENT)
The Impact of System Wide Pulmonary Embolism Screening Program on PERT Activation, Utilization of Advanced Therapies, and 90-Day Outcomes
Pulmonary embolism (PE) remains a high mortality and morbidity disease state. We 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 utility of the current study is to investigate the implementation of an artificial intelligence (AI) program to differentiate patients at the highest risk of the PE spectrum to help efficiently identify those most appropriate for aggressive management. Furthermore, we will investigate the utility of an algorithm-driven protocol for activation of invasive interventions versus traditional PERT discussion and evaluate overall patient outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jun Li, MD
- Phone Number: 440-882-0075
- Email: jun.li@uhhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44416
- University Hospitals Cleveland Medical Center
-
Contact:
- Jun Li, MD
- Phone Number: 440-882-0075
- Email: jun.li@uhhospitals.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Algorithm-driven
|
Following alert by AI program for PE, patients are randomized either to PERT traditional multidiscplinary team discussion (comparator) or to an algorithm-driven protocol (experimental) to decide on treatment strategy.
Treatment strategy may be early invasive-technique or watchful waiting.
|
Active Comparator: PERT-driven
|
Following alert by AI program for PE, patients are randomized either to PERT traditional multidiscplinary team discussion (comparator) or to an algorithm-driven protocol (experimental) to decide on treatment strategy.
Treatment strategy may be early invasive-technique or watchful waiting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-to-activation
Time Frame: 3 days
|
Activation of PERT from time of CT scan to call; compared to historical control
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-minute walk test (6MWT)
Time Frame: 6 minutes
|
The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.
|
6 minutes
|
Length of stay
Time Frame: 30 days
|
Total length of hospital stay
|
30 days
|
Change in quality of life as measured by PEmb QoL
Time Frame: Baseline, 30 days, 90 days
|
PEmb-QoL summary score (0-100, higher score indicate worse outcome)
|
Baseline, 30 days, 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jun Li, MD, University Hospitals
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20220475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Embolism Subacute Massive
-
University of California, Los AngelesEnrolling by invitationPulmonary Disease | Pulmonary Embolism | Pulmonary Embolus/Emboli | Pulmonary Embolism and Thrombosis | Pulmonary Embolism Subacute Massive | Pulmonary Embolism Acute MassiveUnited States
-
Assiut UniversityNot yet recruitingPulmonary Embolism Subacute Massive
-
University of California, Los AngelesMallinckrodtWithdrawnPulmonary Embolism | Pulmonary Embolism Subacute MassiveUnited States
-
Boston Scientific CorporationEKOS CorporationCompletedPulmonary Embolism | Acute Pulmonary Embolism | Pulmonary Thromboembolism | Massive Pulmonary Embolism | Sub-massive Pulmonary EmbolismUnited States
-
Victor Tapson, MDBristol-Myers SquibbTerminatedPulmonary Embolism | Right Ventricular Dysfunction | Right Ventricular Failure | Pulmonary Embolism With Acute Cor Pulmonale | Pulmonary Embolism With Pulmonary Infarction | Pulmonary Embolism Subacute MassiveUnited States
-
Inari MedicalCompletedPulmonary Embolism | Submassive Pulmonary Embolism | Acute Pulmonary Embolism | Massive Pulmonary EmbolismUnited States
-
Supergene, LLCCompletedMassive Pulmonary EmbolismRussian Federation
-
Hospital San Carlos, MadridAsociación de Cardiología Intervencionista de la Sociedad Española de CardiologíaRecruitingPulmonary Embolism | Pulmonary Embolism and Thrombosis | Pulmonary Thromboembolisms | Pulmonary Embolism Acute | Pulmonary Embolism Acute MassiveSpain
-
Meshalkin Research Institute of Pathology of CirculationUnknownAngiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic TherapyRussian Federation
-
Inari MedicalActive, not recruitingPE - Pulmonary Embolism | PE - Pulmonary ThromboembolismUnited States, Spain, Belgium, Germany, France, Switzerland, Netherlands, United Kingdom, Austria
Clinical Trials on Aidoc- Algorithm-driven decision making
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)Enrolling by invitationSubstance-Related Disorders | Opioid-Related DisordersUnited States
-
The University of Texas Health Science Center,...TerminatedPregnancy Related | Elective InductionUnited States
-
Mahidol UniversityUniversity of Medical Technology, YangonCompletedCognitive ChangeMyanmar
-
German Institute of Human NutritionCharite University, Berlin, Germany; Freie Universität Berlin; German Center...RecruitingQuality of Life | Stress, Psychological | BehaviorGermany
-
University of AarhusTrygFonden, DenmarkCompletedCardiovascular Disease | High Cholesterol
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)Completed
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Christiana Care Health ServicesNational Institute of General Medical Sciences (NIGMS); Thomas Jefferson University and other collaboratorsCompleted
-
Massachusetts General HospitalObsessive Compulsive FoundationCompletedObsessive-Compulsive DisorderUnited States