Clinical trial NCT06695247: A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
Official title: Mobility Outcomes in Post-Pulmonary Embolic Disease (MOPED): A Pilot Feasibility Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 using an Interactive Care Plan.


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

Primary outcomes:
measure: Change in physical capacity from baseline
timeFrame: Baseline, 3 Months, 6 Months
Secondary outcomes:
measure: Change in Pulmonary Embolism-specific quality of life (PEmb-QOL) outcome measures from baseline
timeFrame: Baseline, 3 Months, 6 Months
measure: Change in general Short Form 36 (SF-36) quality of life outcome measures from baseline
timeFrame: Baseline, 3 Months, 6 Months
measure: Number of Steps
timeFrame: Baseline, 3 Months, 6 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stan Henkin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: