NCT03253835

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Nov 2013Dec 2027

Study Start

First participant enrolled

November 21, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

12.1 years

First QC Date

August 16, 2017

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Myocardial Injury

patients with myocardial injuries due to ischemic heart disease, patients with myocardial injuries due to non-ischemic heart disease.

Diagnostic Test: Single Group Assignment

No Myocardial Injury

subjects without myocardial injuries with normal cardiac function subjects without myocardial injuries with altered cardiac function

Diagnostic Test: Single Group Assignment

Interventions

Myocardial InjuryNo Myocardial Injury

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to CMR investigation. If suitable and inclusion criteria are met, the patient will be asked if she/he is interested in participating in this study. Participation means, that aside from the respective routine CMR protocol, additional images will be taken within the investigation resulting in 15-20 minutes extra investigation time.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Unitersity Graz, Department of Radiology, Division of General Radiology

Graz, Styria, 8036, Austria

Location

Related Publications (3)

  • 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 2020 Oct 8.

  • 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.

  • Reiter C, Reiter G, Krauter C, Kolesnik E, Greiser A, Scherr D, Schmidt A, Fuchsjager M, Reiter U. Impact of the evaluation method on 4D flow-derived diastolic transmitral and myocardial peak velocities: Comparison with echocardiography. Eur J Radiol. 2024 Jan;170:111247. doi: 10.1016/j.ejrad.2023.111247. Epub 2023 Dec 5.

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael Fuchsjäger, Univ.-Prof.

    Medical Universtiy of Graz

    STUDY CHAIR
  • Ursula Reiter, PD DI Dr.

    Medical Universtiy of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD DI Dr.

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 18, 2017

Study Start

November 21, 2013

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations