Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2021-04-30
2023-11-30
Brief Summary
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Detailed Description
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As described for left atrial fibrosis, the presence and extent of atrial fibrosis can be quantified using CMR late gadolinium enhancement. The protocol for the assessment of left atrial fibrosis will be used and adapted to the RA. Patients will undergo 3-dimensional late gadolinium enhancement CMRI along with a contrast-enhanced magnetic resonance angiography and cine imaging in order to define the anatomy of the RA and the superior and inferior vein. High-resolution late gadolinium enhancement images of the RA will be acquired 15 to 30 min after gadolinium-based contrast agents administration using a 3-dimensional inversion-recovery prepared, respiration navigated, and electrocardiogram triggered gradient-echo pulse sequence with fat saturation. Following acquisition of the scans, the endocardial borders of the RA will be defined in each slice by manual tracing. After manual adjustment of the epicardial RA surface, the quantification of fibrosis based on the relative intensity (signal intensity) of late gadolinium enhancement will be performed. Finally, a 3-dimensional model of the RA will be rendered with the maximum enhancement intensities being projected on the model surface.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pulmonary arterial hypertension
Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg classified into group 1 of the clinical classification of pulmonary hypertension.
cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
Chronic thromboembolic pulmonary hypertension
Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with a history of pulmonary embolism, classified into group 4 of the clinical classification of pulmonary hypertension.
cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
Control
Patients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea.
cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
Interventions
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cardiac magnetic resonance imaging
right atrial late gadolinium enhancement in % and cm2
Eligibility Criteria
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Inclusion Criteria
* Invasive exclusion of pulmonary hypertension
* Age ≥ 18 years
* Signed informed consent
* planned right heart catheterization based on clinical grounds
Exclusion Criteria
* Patients with congenital heart disease
* Atrial septal defects
* Clinical relevant left heart disease
* Atrial fibrillation / Atrial flutter
* Ablations of the right atrium
* History of major cardiac surgery
* Atrial occlude
* Metallic implants
* Pacemakers
* Severe renal impairment (eGFR \< 30 ml/min)
* Other severe disease with a life expectancy below 12 month
* Pregnancy
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results
* Intolerance to a contrast agent containing gadolinium
* Inability to perform a cardiac magnetic resonance imaging (claustrophobia or similar)
18 Years
ALL
Yes
Sponsors
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University of Giessen
OTHER
Responsible Party
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Principal Investigators
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Richter Manuel, MD
Role: PRINCIPAL_INVESTIGATOR
UKGM Giessen
Locations
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Kerckhoff-Klinik
Bad Nauheim, Hesse, Germany
University of Giessen
Giessen, Hesse, Germany
Countries
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Other Identifiers
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AZ 12320
Identifier Type: -
Identifier Source: org_study_id
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