An interventional study of Walking test in Pulmonary Embolism Subacute Massive, sponsored by University Hospitals Cleveland Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.
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Exclusion Criteria:
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.
Diagnostic Test: Walking test
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.
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.
Time-to-activation
Activation of PERT from time of CT scan to call; compared to historical control
Time frame: 3 days
Length of stay
Total length of hospital stay
Time frame: 30 days
6-minute walk test (6MWT)
The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.
Time frame: 6 minutes
Change in quality of life as measured by PEmb QoL
PEmb-QoL summary score (0-100, higher score indicate worse outcome)
Time frame: Baseline, 30 days, 90 days
Plan to share: No
This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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