NCT06695247 · Mayo Clinic
A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2025 · Source of record for eligibility and locations