A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

Mayo Clinic

Status

Enrolling

Conditions

Pulmonary Embolism

Treatments

Other: Exercise Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06695247

24-009493

Details and patient eligibility

About

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 using an Interactive Care Plan.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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