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Validation of MRI measurements in myocardial biopsies

Validation of MRI measurements in myocardial biopsies - Validation of MRI measurements in myocardial biopsies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47680
Enrollment
50
Registered
2019-06-06
Start date
2016-04-29
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cardiac muscle disease cardiomyopathy

Interventions

energy metabolism
fibrosis
myocardium

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (a) Patients with severe aortic valve stenosis who have a clinical indication for surgical aortic valve replacement according to the ESC guidelines, have been accepted for surgery, and have been placed on the waiting list (n=30). (b) Patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction who have a clinical indication for surgical septal myectomy according to the ESC guidelines, have been accepted for surgery, and have been placed on the waiting list (n=20).

Exclusion criteria

Exclusion criteria: 1. Under the age of 18. 2. Renal failure (estimated glomerular filtration rate

Design outcomes

Primary

MeasureTime frame
The main study parameters are: 1. Pre-contrast and post-contrast T1 times as quantified by a MOLLI sequence. Extracellular matrix volume fraction as calculated from myocardial and blood pool pre-contrast and post-contrast T1 and haematocrit. 2. Myocardial creatine content based on 1H-MRS, relative to the total water signal. 3. Myocardial TG content based on 1H-MRS, relative to the total water signal 4. Histological quantification of collagen volume fraction in myocardial biopsies 5. Biochemical quantification of myocardial creatine and triglyceride content.

Secondary

MeasureTime frame
1. Standard cardiac parameters obtained during a routine cardiac MRI protocol, including left and right ventricular end-diastolic and end-systolic volumes, stroke volumes, ejection fractions, left ventricular wall thickness and mass. 2. Routine measurements of plasma glucose, insulin, HbA1c, cholesterol, and lipids will be obtained from blood samples obtained at the time of MRI. 3. MicroRNA levels as measured in myocardial tissue and peripheral blood.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)