The primary objective of this study is to investigate whether circulating fibrotic biomarkers are related to the amount of cardiac fibrosis as determined by MRI in patients. Secondarily, this study aims to investigate whether these biomarkers are…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Cardiac fibrosis determined by contrast MRI at 4-6 months after myocardial
infarction.
- Circulating biomarkers (related to fibrosis) at 4-6 months after myocardial
infarction.
Secondary outcome
- Circulating biomarkers (related to fibrosis) at other time points.
- New circulating biomarkers (related to fibrosis and cardiac function)
- Cardiac function
- Death
- Composite endpoint of non-fatal myocardial infarction, stroke, cardiovascular
hospitalisation or cardiovascular death.
- Heart failure
- Fibrosis determined with new MRI techniques
Background summary
Cardiac adverse remodeling takes place in almost every cardiac disease. A main
determinant of the adverse remodeling is the deposition of connective tissue in
the heart: fibrosis. Fibrosis results in a reduced pump function and an
increased susceptibility to arrhythmias. Early assessment of the adverse
cardiac remodeling is of particular interest for risk stratification and
adjustment of therapy in cardiac patients.
In the clinics, contrast-based MRI is used to determine cardiac fibrosis.
Unfortunately, with this technique only larger patches of fibrosis can be
observed. Therefore, new MRI techniques are currently developed to improve the
detection of cardiac fibrosis.
In the last decade there is also increasing interest in circulating biomarkers;
molecules that reflect biological processes which are detectable in the
circulation. During fibrosis formation, specific fibrotic biomarkers are
released in the blood stream. However, there is only scarce knowledge about the
relation between these biomarkers and cardiac fibrosis. In addition to the
diagnostic tool of biomarkers, biomarkers may also have a prognostic value.
Recently, new potential biomarkers have been identified by the Experimental
Cardiology Department (UMC Utrecht) that might be related to the progression of
heart failure after a myocardial infarction.
Study objective
The primary objective of this study is to investigate whether circulating
fibrotic biomarkers are related to the amount of cardiac fibrosis as determined
by MRI in patients. Secondarily, this study aims to investigate whether these
biomarkers are related to cardiac function and the prognosis of the MI
patients.
In addition, this study serves as a pilot to identify new circulating
biomarkers that are associated with fibrosis and cardiac function. Also the
predictive and prognostic value of these biomarkers is investigated.
Next to the biomarker investigation, this study is used as pilot-study to
investigate promising new MRI techniques that may be used for fibrosis
detection. These new MRI techniques are compared to the contrast-based MRI
technique.
Study design
Patients with an acute myocardial infarction are followed in time (78
patients). Blood is drawn at four time points to evaluate biomarker levels. At
three time points, the patient undergoes MRI and echocardiography to evaluate
the cardiac function and cardiac fibrosis.
Study burden and risks
Burden:
For study purposes, the subjects will come back to the UMC Utrecht twice. The
total burden for the subjects will be ± 5 hours (3 extra MRIs, one extra echo,
and blood withdrawal). The subject may experience laying down without movement
and the small space in the MRI as a burden.
Risks:
There are hardly any risks associated with study participation. All study
procedures are according to standard procedures in the UMC Utrecht and are also
used in daily practice. The possible risks are related to the MRI:
claustrophobia, kidney toxicity, and a reaction against the contrast agent.
Yalelaan 50
Utrecht 3584 CM
NL
Yalelaan 50
Utrecht 3584 CM
NL
Listed location countries
Age
Inclusion criteria
Subject is diagnosed with acute myocardial infarction.
Subject is 18 years or older.
Exclusion criteria
Subject with known prior acute myocardial infarction, cardiac surgery, or valvular diseases.
Subject is implanted with MRI incompatible prostheses or devices.
Subject has an indication for implantable cardio defibrillator.
Subject is in a condition that alters the collagen turnover.
Subject underwent recent trauma or surgery in the last 6 months.
Subject is diagnosed with kidney failure.
Subject is known with an allergy against gadolinium-based contrast agents.
Subject is familiar with claustrophobia.
Subject is pregnant or has given birth within the past 90 days.
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 | NL45241.041.13 |