Condition category
Circulatory System
Date applied
19/10/2020
Date assigned
26/11/2020
Last edited
26/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to examine the interaction of alterations of blood flow to the heart and great vessels in patients with thickening of the left heart muscle due to various causes.

Who can participate?
Patients with aortic valve pathologies, aneurysms of the aorta, hypertropic cardiomyopathy, or mitral valve diseases

What does the study involve?
The study involves cardiovascular magnetic resonance imaging (MRI) examinations with contrast agent. This examination will be repeated after 1, 3 and 5 years

What are the possible benefits and risks of participating?
The patients and their doctors will receive information about all the results that are collected during the examination. The risks for participants are vascular, skin and nerve lesions through the peripheral venous indwelling cannula as well as possible contrast medium allergy.

Where is the study run from?
Charité - Universitätsmedizin Berlin (Germany)

When is the study starting and how long is it expected to run for?
April 2020 to December 2025

Who is funding the study?
Funding is currently being applied for

Who is the main contact?
Univ.-Prof. Jeanette Schulz-Menger
jeanette.schulz-menger@charite.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ralf Felix Trauzeddel

ORCID ID

Contact details

AG Kardiale MRT
Campus Buch
Charité – Universitätsmedizin Berlin
Experimental and Clinical Research Center
eine gemeinsame Einrichtung von Charité und MDC
Lindenberger Weg 80
Berlin
13125
Germany
+49 (0)30 450 540616
ralf-felix.trauzeddel@charite.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EA1/185/20

Study information

Scientific title

Characterization of the interaction of intra- and extracardiac hemodynamics with myocardial and vascular remodelling using cardiovascular magnetic resonance imaging: a prospective observational study (Charakterisierung der Interaktion von intra- und extrakardialer Hämodynamik mit dem myokardialen und vaskulären Remodelling mittels kardiovaskulärer Magnetresonanztomographie: eine prospektive Observationsstudie)

Acronym

MRCorVasc

Study hypothesis

1. There are no relevant differences in the quantitatively detectable three-dimensional, time-resolved cardiovascular MRI measurement methods of hemodynamics (forward flow) between the imaging of the thoracic aorta on the one hand and the detection of the entire heart and the large intrathoracic vessels on the other hand, which exceed the already existing intra-individual variability between the individual heartbeats.
2. Changes in hemodynamics lead to remodelling of the heart and vessels and vice versa as well as to outcome differences (e.g. left ventricular hypertrophy, increase in diameter of the thoracic and abdominal aorta, differences in timing of surgical and interventional procedures) over the course of the disease.
3. A characterization of hemodynamics by imaging the entire heart allows a more differentiated consideration of the effects on myocardial remodelling and quantitative tissue parameters than the isolated consideration of hemodynamics by imaging the thoracic aorta alone.
4. There are no relevant differences from other quantitatively measurable parameters of hemodynamics, which are recorded by three-dimensional time-resolved cardiovascular MRI measurement methods (e.g. backward flow, regurgitation fraction, wall shear forces, deviations of blood flow from the center of the vessel (so-called normalized flow displacement), kinetic energy (KE), measurements of energy loss in turbulent flows (so-called turbulent kinetic energy (TKE), pulse wave velocity, pressure gradients, Jet Shear Layer Detection, Viscous Energy Loss Rate (VELR) and Pressure Drop) between imaging of the thoracic aorta as a sequence on the one hand and the detection of the entire heart and the large intrathoracic vessels on the other hand, which go beyond the already existing intraindividual variability between the individual heartbeats.
5. There are no relevant differences between non-accelerated and accelerated sequences for two-dimensional recording of hemodynamics in the thoracic aorta, both in real-time and in segmented measurement.
6. There are no relevant differences between time-resolved three-dimensional accelerated sequences on the one hand and two-dimensional sequences on the other.
7. By means of novel techniques for two-dimensional acquisition of hemodynamics, which combine different codes of maximum velocities in one measurement, it is possible to correctly characterize combined high-grade aortic valve diseases.

Ethics approval

Approved 18/09/2020, Research Ethics Committee of the Charité - Universitätsmedizin Berlin (Charitéplatz 1, 10117 Berlin, Germany; +49 (0)30 450 517222; ethikkommission@charite.de), ref: EA1/185/20

Study design

Prospective observational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Interaction of myocardial damage and intra- and extracardial hemodynamics in patients with left ventricular hypertrophy of various causes, as well as the investigation of underlying valvular defects and their influence on changes in the major vessels

Intervention

Two-dimensional and three-dimensional time-resolved sequences of flow using cardiovascular magnetic resonance imaging are used, which represent the aorta individually as well as the entire heart with inflowing and outflowing vessels. Furthermore, sequences of ventricular function, myocardial tissue characterization and the representation of the vascular anatomy are used.

The following images are taken:
1. Overview images for anatomy representation (approx. 5 min)
2. bSSFP cine images for functional analysis (approx. 5 min) with determination of left and right ventricular function (in %) and mass (in g and indicated on the body surface) as well as ventricular and atrial volumes (in ml and indicated on the body surface) and dimensions (in mm and indicated on the body surface)
3. 2D and 4D flow measurements (approx. 20 min) with determination of basic and advanced parameters of hemodynamics (forward, backward flow (in ml/cycle), regurgitation fraction (in %), maximum and average velocities (in m/s), Wall shear forces as a measure of the tangential force acting on the vessel wall (in Pa), normalized flow displacement as a measure of the deviation of the flow from the vessel center in terms of eccentricity (in mm), KE and TKE as a quantitative measure of flow turbulence (in J/m3 or J/ml), VELR as a measure of frictional loss between the flow layers (in J/m3 or J/ml), pulse wave velocity as an indicator of vessel stiffness, pressure gradients as the driving force of the flow (in mmHg), jet shear layer detection to illustrate the influence of constrictions on the blood flow (without unit of measurement) and pressure drop in the sense of a pressure loss as an additional quantitative measure of a constriction in the cardiovascular system (in mmHg)
4. T1, T2 and T2* measurements for tissue characterization to detect fibrosis, edema and extracellular volume (approx. 15 min) with determination of T1, T2 and T2* times (in ms)
5. Myocardial fat imaging
6. Contrast-free angiography for vessel imaging (approx. 10 min) with determination of the diameters of the vessels and their wall thicknesses (in mm)
7. Unique imaging of myocardial scars and fibroses using Lade Gadolinium Enhancement after administration of contrast medium during baseline examination

The researchers also plan to re-examine the patients after an interval of 1, 3 and 5 years. Furthermore, a questionnaire will be sent out every 6 months. In addition, as part of the study clarification, participants are asked to contact the study physicians at any time in the event of corresponding symptoms, in the event of a deterioration of the findings, which are recorded in the course of external and other diagnostic procedures, as well as prior to elective surgery and interventions that affect the pathology to be investigated, in the course of which the study was included. If necessary, a repeat study examination will then be performed outside the above-mentioned time intervals. This will serve to document the findings in the context of the long-term observation planned in this study. The results of all examinations and data on the efficiency of the examinations are recorded for each examination. During the MRI examination, blood pressure and pulse are continuously monitored and documented.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Forward flow assessed by cardiovascular magnetic resonance imaging at baseline, 1, 3, and 5 years

Secondary outcome measures

Measured by three-dimensional, time-resolved cardiovascular MRI at baseline, 1, 3, and 5 years:
1. Backward flow
2. Regurgitation fraction
3. Wall shear forces
4. Deviations of blood flow from the center of the vessel (so-called normalized flow displacement)
5. Kinetic energy (KE)
6. Measurements of energy loss in turbulent flows (so-called turbulent kinetic energy (TKE))
7. Pulse wave velocity
8. Pressure gradients
9. Jet shear layer detection
10. Viscous energy loss rate (VELR)
11. Pressure drop

Overall trial start date

01/04/2020

Overall trial end date

31/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. One of the following pathologies: aortic valve stenosis (moderate or severe), aortic valve insufficiency (moderate or severe), mitral valve insufficiency (moderate or severe), hypertrophic cardiomyopathy (with or without obstruction), dilation or aneurysm of the thoracic aorta or abdominal aorta
2. Written informed consent to participate in the study
3. Existing health insurance, so that in case of incidental findings, these can be clarified
4. Study subjects agree to the communication of incidental findings
5. Aged over 17 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5 clusters including 30 participants in each cluster

Participant exclusion criteria

1. Agoraphobia
2. Contraindication for an MRI
3. Contraindication for an MRI contrast agent
4. Pregnancy, lactation
5. Severe renal insufficiency

Recruitment start date

01/01/2021

Recruitment end date

31/12/2025

Locations

Countries of recruitment

Germany

Trial participating centre

Charité – Universitätsmedizin Berlin
Working group on cardiovascular magnetic resonance imaging Campus Buch Experimental and Clinical Research Center, eine gemeinsame Einrichtung von Charité und MDC Lichtenberger Weg 80
Berlin
13125
Germany

Sponsor information

Organisation

Charité

Sponsor details

Campus Buch
Experimental and Clinical Research Center
eine gemeinsame Einrichtung von Charité und MDC
Lindenberger Weg 80
Berlin
12125
Germany
+49 (0)30 450 540616
ralf-felix.trauzeddel@charite.de

Sponsor type

University/education

Website

http://www.charite.de/en/charite/

Funders

Funder type

Other

Funder name

Pending

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. Additional documents will be available upon request.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Univ.-Prof. Jeanette Schulz-Menger (jeanette.schulz-menger@charite.de).

Intention to publish date

31/12/2026

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/10/2020: Trial's existence confirmed by the Research Ethics Committee of the Charité - Universitätsmedizin Berlin.