NCT06695247 A Study of Mobility Outcomes in Post-Pulmonary Embolic Disease
| NCT ID | NCT06695247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Pulmonary Embolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Stan Henkin, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06695247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06695247 currently recruiting?
Yes, NCT06695247 is actively recruiting participants. Contact the research team at Henkin.Stanislav@mayo.edu for enrollment information.
Where is the NCT06695247 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06695247 clinical trial?
NCT06695247 is sponsored by Mayo Clinic. The principal investigator is Stan Henkin, M.D. at Mayo Clinic. The trial plans to enroll 100 participants.