The Venous Congestion Validation Study
Recruiting
- Conditions
- venous congestion1008220610057166
- Registration Number
- NL-OMON46220
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
* Adult patients (i.e. >18 years of age)
* Receiving right-heart catheterization for a clinical indication
Exclusion Criteria
* Contra-indication for MRI or unable to undergo MRI protocol due to physical condition ;* Participation in ongoing trials for therapeutic interventions including randomized controlled trials and clinical trials of investigational medicinal products
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary endpoint will be a minimal clinically useful correlation of 0.6 or<br /><br>higher between right atrial pressure in mmHg measured directly during right<br /><br>heart catheterization, and indirectly assessed by MRI measurements of flow<br /><br>pattern and dimension changes of vena cava superior.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are defined as:<br /><br>i. A minimal clinically useful correlation of 0.6 or higher between pressures<br /><br>in mmHg, measured during right heart catheterization and MRI.<br /><br>ii. A minimal clinically useful correlation of 0.6 or higher between pressures<br /><br>in mmHg, measured during right heart catheterization and echocardiographic<br /><br>measurements of RAP (vena cava inferior). Additionally, echocardiographic<br /><br>measurement of vena jugularis interna flow will be included.<br /><br>iii. The association between measurements of echocardiography and MRI.</p><br>