Neurological Monitoring during pulmonary endarterectomy (PEA) and balloon pulmonary angioplasty (BPA) for chronic thrombo-embolic pulmonary hypertension (CTEPH)

Neurological Monitoring during pulmonary endarterectomy (PEA) and balloon pulmonary angioplasty (BPA) for chronic thrombo-embolic pulmonary hypertension (CTEPH) - NEMO CTEPH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54062

Enrollment

Registered

2023-06-15

Start date

2022-12-04

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension (CTEPH) high blood pressure in the bloodvessels of the lungs due to persistent thrombosis in the pulmonary arteries

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic thromboembolic pulmonary hypertension undergoing  pulmonary endarteriectomy or Balloon Pulmonary Angioplasty. 2. Capable of giving informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Post-operatiev cognitive decline (POCD) as measured by a decrease in the adjusted score of 4 validated cognitive tests as part of a neuropsychological evaluation at 3 and 6 months after the procedure.	—

Secondary

Measure	Time frame
Incidence of delirium in the clinical post-treatment phase. Difference in changes of the selected neurobiomarkers (NfL, GFAP, p-tau) in plasma of patients after undergoing either BPA or PEA.	—

Countries

Netherlands

Outcome results