Mobility Outcomes in Post-Pulmonary Embolic Disease

Overview

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Age ≥18 to ≤ 80 years old

    - 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 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/30/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stanislav Henkin, M.D.

Contact us for the latest status

Contact information:

Preventive Heart Research Team

(507) 538-7425

rstcvruprevent@mayo.edu

More information

Publications

Publications are currently not available