eurological Monitoring during pulmonary endarterectomy (PEA) and balloon pulmonary angioplasty (BPA) for chronic thrombo-embolic pulmonary hypertension (CTEPH)
- Conditions
- Chronic thromboembolic pulmonary hypertension (CTEPH)high blood pressure in the bloodvessels of the lungs due to persistent thrombosis in the pulmonary arteries1003745410003184
- Registration Number
- NL-OMON54062
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Patients with chronic thromboembolic pulmonary hypertension undergoing
pulmonary endarteriectomy or Balloon Pulmonary Angioplasty.
2. Capable of giving informed consent
Exclusion Criteria
1. Severe neuropsychological comorbidity
2. Inability to provide informed consent
3. Being analphabetic
4. Insufficient understanding of the Dutch language
5. Scoring positive for dementia during the preoperative neuropsychological
evaluation
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Post-operatiev cognitive decline (POCD) as measured by a decrease in the<br /><br>adjusted score of 4 validated cognitive tests as part of a neuropsychological<br /><br>evaluation at 3 and 6 months after the procedure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of delirium in the clinical post-treatment phase.<br /><br>Difference in changes of the selected neurobiomarkers (NfL, GFAP, p-tau) in<br /><br>plasma of patients after undergoing either BPA or PEA.</p><br>