Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using MRI

NCT05161884 | Unknown

• 1 other identifier: EA4/118/20
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• oxygenation within the blood measured with MRI versus catherization

  Comparison of the accuracy of BOLD MRI versus right heart catheterization (RHC)

  1 Year

• differences in oxygenation within different heart failure groups

  Analysis of the sensitivity of BOLD measurements as a new diagnostic method for dyspnea at first presentation for various clinical applications

  1 Year

Study Arms (6)

Preclinical Study group

n=10 Landrace pigs The aim of the pre-clinical study was to assess the accuracy of BOLD-T2 MRI in acute systemic hyper- and hypoxemia in a porcine model in contrast to cardiac catheterization.

Validation Study group

n=25 The patients have an indication for a right heart catheter examination. This is a routine diagnostic examination that is performed on these patients. Compared to the clinical routine, an additional MRI measurement will be performed. The measurement will be performed before the cardiac catheterization. For the MRI examination, the patient/subject is placed in a magnetic resonance imaging machine. The MRI examination initially includes approximately 15 minutes of standard images for orientation and determination of function, morphology, and tissue characteristics. This is followed by images to determine oxygen saturation in the ventricles (approximately 5 minutes). If a CMR examination is already planned for a patient for other reasons, this will only be extended by the recordings for the determination of oxygen saturation (approx. 5 minutes) at the time of study inclusion. During the MRI measurements, patients will also perform a stepper stress test.

Pulmonary Hypertension group

n=25 patients with pulmonary hypertension (definition: pulmonary arterial pressure (PAP) above 25 mmHg)

Valvular heart disease group

n=25 patients with valvular heart disease (at least moderate)

Ischemic cardiomyopathy group

n=25 patients with ischemic cardiomyopathy

HFpEF group

n=25 patients with HFpEF (heart failure with preserved ejection fraction, definition: EF over 50%, heart failure symptoms, elevated NT-proBNP over 400pg/ml)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All male and female patients (age ≥ 18 years) of the Cardiology Clinic at Campus Virchow Klinikum and Deutsches Herzzentrum Berlin will be screened with regard to inclusion and exclusion criteria. Patients eligible on the basis of these criteria will be included in the study after informed consent and written consent. I Part (validation) In the first part of the study (the validation), a total of 25 patients were to be scheduled for right heart catheterization. II part (clinical study) In the second part will be a total of 100 patients with dyspnea and clinical indication for MRI and 25 healthy control patients.

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years. Pregnancy (for women of childbearing age, a pregnancy test is performed if pregnancy is possible) or breastfeeding.
• 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

Sponsors & Collaborators

• German Heart Institute: lead

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

• Alogna A, Faragli A, Kolp C, Doeblin P, Tanacli R, Confortola G, Oetvoes J, Perna S, Stehning C, Nagel E, Pieske BM, Post H, Kelle S. Blood-Oxygen-Level Dependent (BOLD) T2-Mapping Reflects Invasively Measured Central Venous Oxygen Saturation in Cardiovascular Patients. JACC Cardiovasc Imaging. 2023 Feb;16(2):251-253. doi: 10.1016/j.jcmg.2022.08.020. Epub 2022 Nov 16. No abstract available.

  PMID: 36648039 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sebastian Kelle

  German Heart Center Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Kelle, MD, PhD

CONTACT

00493045932400; kelle@dhzb.de

Sebastian Kelle

CONTACT

01751583634; sebastiankelle@gmx.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac MRI

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 17, 2021
• Study Start: April 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

DE (1)