A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease

Launched by MAYO CLINIC · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is focusing on how home-based exercise can help patients recover after experiencing a pulmonary embolism (PE), which is a condition where a blood clot blocks blood flow to the lungs. The study aims to create a personalized exercise plan with the help of experts in heart care, making it easier for patients to improve their mobility at home. The trial is currently looking for participants aged 65 to 74 and those between 29 and 219 years old, and both men and women are welcome to join.

To be eligible for this study, participants need to have experienced a recent pulmonary embolism that is classified as either intermediate or high-risk, based on specific imaging tests that show heart function and blood flow. Participants should be able to walk independently, but those who need supplemental oxygen during exercise can still take part. If you decide to join, you will follow a home exercise program and have follow-up visits at 3 and 6 months to see how you are doing. This trial is an opportunity to contribute to improving recovery options for others with similar conditions while also potentially benefiting your own health.

Gender

ALL

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