Status:
RECRUITING
A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
Lead Sponsor:
Mayo Clinic
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists usin...
Eligibility Criteria
Inclusion Criteria:
Acute intermediate-risk PE, defined as:
- Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
- Evidence of right ventricular enlargement by computed tomography (RV to LV ratio >1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition.
Acute high-risk PE, defined as:
- Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
- Evidence of right ventricular enlargement by computed tomography (RV to LV ratio >1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition; AND
- Hypotension (systolic blood pressure < 90 mm Hg sustained for more than 15 minutes; or requiring vasopressors) or cardiogenic shock due to acute pulmonary embolism.
Exclusion Criteria:
- Inability to ambulate independently, which is necessary to perform 6MWD (may be self-reported or as deemed by physical therapy during inpatient evaluation).
- If patient requires supplemental oxygen during ambulation, this does not exclude patient from participation and will be noted during eCRF.
- Prior history of pulmonary embolism
- History of CTEPH or pulmonary arterial hypertension
- Unable to read a questionnaire in English
- Unable to return for baseline, 3- or 6-month follow-up visit
- Pregnancy-associated pulmonary embolism
- Life expectancy <1 year based on comorbidities
- Unable/unwilling to provide informed written consent
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06695247
Start Date
July 14 2025
End Date
December 1 2026
Last Update
August 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905