Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using MRI (NCT05161884) | Clinical Trial Compass
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Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using MRI
Germany135 participantsStarted 2021-04-01
Plain-language summary
BOLD measured with MRI may be a useful noninvasive method for the assessment of right ventricular O2 saturation. A validation of this method against right heart catheterization has not been fully performed. Whether the method may have a diagnostic and prognostic role in chronic heart failure patients is unclear.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Age \> 18 years Ability to follow the study according to study protocol General ability to consent Presence of a written consent of the study participant Patients with a clinical indication for right heart catheterization
Exclusion Criteria:
Age \<18 years. Pregnancy (for women of childbearing age, a pregnancy test is performed if pregnancy is possible) or breastfeeding.
Any condition that interferes with informed decision making General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes) Any MRI exclusion criteria not listed here as determined by the performing MRI laboratory.
Hemodynamically unstable patients (heart rate \< 50/min, systolic blood pressure \< 90 mmHg, circulatory support devices: IABP, Impella) Complex supra- or ventricular arrhythmia occurring at rest or on exertion Right ventricular thrombus Recent pulmonary embolism Pulmonary instability (oxygen depletion or peripheral oxygen saturation \<90%) Chronic lung disease (FEV\< 35% on spirometry) Claustrophobia Sensorineural hearing loss from 30 dB and tinnitus
What they're measuring
1
oxygenation within the blood measured with MRI versus catherization
Timeframe: 1 Year
2
differences in oxygenation within different heart failure groups