Examination of the interaction of alterations of blood flow in the heart and great vessels with changes of the blood vessels and heart muscle using cardiovascular magnetic resonance imaging: an observational study

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN35168483

Enrollment

150

Registered

2020-11-26

Start date

2021-01-01

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Circulatory System

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026