Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage

Healthy Clinical Trial

— CMR-LHD  

Official title:

Cardiac Blood Flow Patterns Associated With Regional and Global Left Ventricular Myocardial Damage: an Explorative Study by Cardiac Magnetic Resonance

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03253835
• Other study ID #: CMR-12-LHD
• Status: Enrolling by invitation
• Start date: November 21, 2013
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Various factors affect the performance of the heart: The contractile properties of myocardial muscle cells are the fundamental devices for translating tension-generation and shortening of the cardiac muscle into pressure-generation and blood volume ejection from the heart into the body. On the other hand, the performance of heart can be analyzed with respect to input and output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood volume, blood flow and pressures are linked by hemodynamic laws. Cardiac magnetic resonance (CMR) is the "gold standard technique" to determine cardiac function and muscle mass, as well as for non-invasive diagnosis of myocardial necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of myocardial magnetic relaxation times for characterization of myocardial morphology and the acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and surrounding vessels, represent promising tools for the evaluation of the interaction between myocardial morphology and cardiac function. Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation dynamics …) with myocardial injuries.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients age 20-80 years,
• patients with and without ischemic or non-ischemic myocardial injuries scheduled for routine cardiac magnetic resonance imaging,
• ability to hold the breath,
• ability to give informed consent

Exclusion Criteria:

• patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for magnetic resonance investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, colored contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
• patients with tendency toward claustrophobia,
• hemodynamically unstable patients,
• patients with (major) arrhythmia
• pregnancy,
• impaired kidney function indicated by creatin clearance lower than 60 ml/min (creatin clearance will be calculated according to Cockroft-Gault formula)

Related Conditions & MeSH terms

• Cardiomyopathies
• Healthy
• Myocardial Injury

Intervention

Diagnostic Test:
• Single Group Assignment

Locations

Country	Name	City	State
Austria	Medical Unitersity Graz, Department of Radiology, Division of General Radiology	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Anniversary Fund of the Oesterreichische Nationalbank

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Krauter C, Reiter U, Reiter C, Nizhnikava V, Masana M, Schmidt A, Fuchsjager M, Stollberger R, Reiter G. Automated mitral valve vortex ring extraction from 4D-flow MRI. Magn Reson Med. 2020 Dec;84(6):3396-3408. doi: 10.1002/mrm.28361. Epub 2020 Jun 18. — View Citation

Krauter C, Reiter U, Reiter C, Nizhnikava V, Schmidt A, Stollberger R, Fuchsjager M, Reiter G. Impact of the Choice of Native T1 in Pixelwise Myocardial Blood Flow Quantification. J Magn Reson Imaging. 2021 Mar;53(3):755-765. doi: 10.1002/jmri.27375. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial pathology-associated blood flow patterns in the heart and surrounding great vessels	Morphologic, functional and blood flow CMR parameters will be evaluated with different techniques. Cardiac blood flow pattern parameters will be correlated with myocardial injury derived non-invasively from late gadolinium enhancement	2 years