Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CTEPH. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics
Overview
Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.
Primary outcome measures
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
Secondary outcome measures (3)
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
- Impact of BPA on cardio-pulmonary vascular physiology [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patient referred to BPA
- clinical indication for CMR
- capability to give informed consent
Exclusion criteria
- general: non-compliance, <18 years of age, pregnancy
- contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- Kerckhoff-Klinik — Bad Nauheim
Identifiers
NCT: NCT07299227 · AZ 158/24