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)

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Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905