The feasibility of direct-detection of fibrotic tissue will be assessed in patients with a healed myocardial infarction and in patients with cardiomyopathy using LGE as reference standard.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the fraction of myocardial fibrosis on
LGE images (reference standard), which are detected on direct MR fibrosis
images.
Secondary outcome
-
Background summary
The deposition of fibrosis after a myocardial infarction and in patients with
cardiomyopathy decreases the contractility of the heart and may cause
arrhythmias. Late gadolinium enhancement (LGE) Magnetic Resonance Imaging (MRI)
is frequently used to evaluate the presence and extent of myocardial fibrosis,
but its use increases scan time duration and may cause allergic reactions.
Direct-detection of myocardial fibrosis using MRI is free from these
limitations.
Study objective
The feasibility of direct-detection of fibrotic tissue will be assessed in
patients with a healed myocardial infarction and in patients with
cardiomyopathy using LGE as reference standard.
Study design
Cross-sectional diagnostic study.
Study burden and risks
There are minimal risks regarding the use of gadolinium contrast. All subjects
will be screened on allergy for contrastagents and the renal function will be
assessed if unknown. Furthermore, no short and long term adverse effects of the
MRI scanner on the human body are known.
Only in patients with cardiomyopathy and healthy volunteers (diffuse fibrosis),
2 ml blood will be withdrawn from the intravenous infusion that will be used
for administration of the MR contrast agent. Therefore the additional risk is
negligible,
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Treatment group:
- 18 years or older
- previous history of myocardial infarction
- cardiomyopathy
- eligible to give informed consent
Control group:
- age-matched healthy controls
- eligible to give informed consent
Exclusion criteria
- pregnancy or possible pregnancy
- lactation
- documented allergic reaction to gadolinium
- subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2)
- impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41282.041.12 |