Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06784492
Eligibility Criteria:
Inclusion Criteria:
1. English speaking (\>18 years old). Daily messages will be sent in English.
2. Acute PE with at least one of the following:
1. any right ventricular enlargement or dysfunction on echocardiogram;
2. CT Angiogram reporting any right ventricular enlargement; or
3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
3. Rate controlled atrial arrythmias (resting heart rate \<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
4. Subjects do need to take prescribed anticoagulation.
Exclusion Criteria:
1. Pregnancy.
2. Cardiac Effort \>3.5 beats/m during 6MWT.
3. Resting tachycardia \>110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure \>180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06784492
Study Brief:
Protocol Section:
NCT06784492