Validation of MRI measurements in myocardial biopsies

Completed

Conditions: cardiomyopathy
10028593
Cardiac muscle disease

Registration Number: NL-OMON47680

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

1. Under the age of 18.
2. Renal failure (estimated glomerular filtration rate < 30 ml/min).
3. Claustrophobia or another contra-indication for MRI.
4. Not able to provide written informed consent.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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