To evaluate plaque burden and characteristics in early-treated FH patients and to compare coronary plaque burden and characteristics between early- and late-treated FH patients as well as with non-FH controls.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter to study will be the total coronary plaque volume.
Secondary outcome
The secondary study parameters to be studied will be the following:
• Presence of obstructive stenosis (and number of vessels)
• Presence of any stenosis (and number of vessels)
• Calcified plaque volume
• Non-calcified plaque volume
• Number and presence of high-risk plaque features, i.e.:
o positive remodelling (RI>1.1)
o low attenuation plaque (<= 30 HU)
o spotty calcification
o napkin ring sign
• Fat attenuation index (FAI)
• Lipid parameters
Background summary
It has been shown that early lipid lowering treatment in familial
hypercholesterolemia (FH) patients reduces CVD events at the mean age of 32. It
is not known what the effect of early treatment is on coronary plaque burden in
these patients.
Study objective
To evaluate plaque burden and characteristics in early-treated FH patients and
to compare coronary plaque burden and characteristics between early- and
late-treated FH patients as well as with non-FH controls.
Study design
Single center, observational, cross-sectional study.
Study burden and risks
The results of this study contribute to the understanding of the effects of
early statin-treatment in FH patients. It is not known whether these patients
will experience CVD events at a later age and how this early treatment affects
coronary plaque development.
Participating FH patients or non-FH controls in this study receive no direct
clinical benefits from clinical CCTA imaging. However, the expected risk for
participants is low. The most important risk in this study is radiation
exposure. However, the maximum exposure related to CCTA imaging is 1.4 mSv.
This a low radiation exposure and is lower than the yearly dose of background
radiation in the Netherlands. Furthermore, ionized contrast agents will be used
during CCTA, which can be nephrotoxic and may elicit allergic reactions. In
addition, incidental extra-coronary findings, such as pulmonary malignancies,
can be a potential benefit from CCTA imaging since early detection of these
findings may enable early treatment. Cardiac findings, such as significant
coronary lesions, will be left at the discretion of the treating physician.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with heterozygous familial hypercholesterolemia or non-FH control
- Adult patients between 25 and 55 years old
Exclusion criteria
- Renal insufficiency, defined as eGFR < 30 ml/min
- Atrial fibrillation
- Any other treatment or clinically relevant condition that could interfere
with the conduct or interpretation of the study in the opinion of the
investigator
- Inability or unwillingness to comply with the protocol requirements, or
deemed by investigator to be unfit for the study.
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 | NL79640.018.21 |