First, non-invasive diagnostic tools can optimize the diagnostic strategy, in order to minimize the number of invasive diagnostic procedures. Second, invasive imaging of the pulmonary artery can further differentiate the mechanisms involved in…
ID
Bron
Verkorte titel
Aandoening
Pulmonary hypertension, pulmonary sarcoidosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Non-invasive diagnosis of pulmonary hypertension in pulmonary sarcoidosis.
Doel van het onderzoek
First, non-invasive diagnostic tools can optimize the diagnostic strategy, in order to minimize the number of invasive diagnostic procedures.
Second, invasive imaging of the pulmonary artery can further differentiate the mechanisms involved in PH associated sarcoidosis.
Onderzoeksopzet
The first timepoint is the initial diagnostic screening, including right heart catheterization and IVUS if indicated. All diagnostic procedures will be performed within weeks from each other.
The second timepoint, only for patients diagnosed as no pulmonary hypertension, is after one year of initial screening.
Onderzoeksproduct en/of interventie
All patients will be screened for the presence of pulmonary hypertension by a standardized diagnostic strategy (Local standard protocol) including history taking and physical examination, electrocardiogram and biomarkers related to pulmonary hypertension (NT-pro BNP, troponin and uric acid) and echocardiography with additional 3D-echocardiography (Ventripoint® system) in order to assess right ventricle volume and function measurements (). In a subgroup of patients with the diagnosis PH possible or likely based on the diagnostic strategy (as suggested by the international guidelines for pulmonary hypertension), right heart catheterization will be performed to measure pulmonary hemodynamics. Additionally, this will include intravascular imaging of the pulmonary artery using IVUS (Revolution® 45 MHz Rotational IVUS Imaging Catheter).
Algemeen / deelnemers
Marloes P. Huitema
Koekoekslaan 1
Nieuwegein 3534CM
The Netherlands
Tel: 030 - 609 80 99
Email: mp.huitema@antoniusziekenhuis.nl
Wetenschappers
Marloes P. Huitema
Koekoekslaan 1
Nieuwegein 3534CM
The Netherlands
Tel: 030 - 609 80 99
Email: mp.huitema@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Diagnosis of pulmonary sarcoidosis conforming the American Thoracic Society (ATS) criteria (confirmed by histology or cytology) or by consensus of a multidisciplinary ILD-team
- Age 18 years or above
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
For 3D-echocardiography:
- Pacemaker or Implantable Cardioverter Defibrillator (ICD)
For IVUS and right heart catheterization:
- Right heart mass (thrombus and/or tumor)
- Patients with coagulopathy
- Tricuspid or pulmonary valve mechanical prosthesis
- Endocarditis of tricuspid or pulmonary valve
- Frequent ventricular arrhythmias
For IVUS only
- Allergy to contrast
- Glomerular Filtration Rate (GFR) <30 mL/min/1.73m2 as calculated by the Cockcroft-Gault Equation
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5155 |
NTR-old | NTR5295 |
Ander register | ZonMW : 80-84200-98-15225 |