To determine whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, aggressive lipid lowering therapy (statins, ezetimibe and/or PCSK9) according to…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter to study will be the mean plaque progression (absolute
difference in total plaque volume between the initial and follow-up CCTA scan).
Secondary outcome
The secondary study parameters to be studied will be the following:
• Relative mean plaque progression
• Number 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
• Difference in non-calcified plaque volume between baseline and follow-up CCTA
(delta non-calcified plaque volume)
• Difference in calcified plaque volume between baseline and follow-up CCTA
(delta calcified plaque volume)
• Difference in fat attenuation index (FAI) between initial and follow-up CCTA
scan
• Lipid parameters
Background summary
It is believed that early (at a young age) aggressive lipid lowering treatment
can reverse atherosclerotic plaque formation and sometimes cure
atherosclerosis, in contrast to the inability of plaques to regress in older
patients. We recently substantiated this concept by a case series of two
adolescent null/null homozygous familial hypercholesterolemia (FH) patients who
showed an unprecedented ~80% plaque reduction after aggressive lipid lowering
therapy with statins, ezetimibe, LDL apheresis, enforced with PCSK9 inhibition.
Study objective
To determine whether plaques in young patients with familial
hypercholesterolemia (aged below 50 years) are susceptible to significant
plaque regression with early, aggressive lipid lowering therapy (statins,
ezetimibe and/or PCSK9) according to clinical guidelines.
Study design
Serial CCTA imaging before and 30-40 weeks after aggressive lipid lowering
therapy.
Study burden and risks
Participating subjects in this study receive no direct clinical benefits from
participation in this study, except for optimalization of their LDL cholesterol
lowering regimen according to current clinical practice/guidelines. The burden
and risk of participating in this study is estimated to be low. The study
requires three visits. Blood withdrawal for clinical laboratory assessment will
be limited to 41.5 ml. Patients will be exposed to a limited radiation burden
related to CCTA imaging (2.8 mSv). Furthermore, there is a very small risk of
contrast nephropathy.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with heterozygous familial hypercholesterolemia
- Adult between 18 and 50 years old
- LDL cholesterol levels above 100 mg/dl (>2.6 mmol/L) at inclusion
Exclusion criteria
- Renal insufficiency, defined as eGFR < 30 ml/min
- History of atherosclerotic cardiovascular events
- 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 | NL75337.018.20 |