AGELESS has 3 specific aims - they all refer to patients with carotid atherosclerosis:1. To compare patients with and without carotid intraplaque hemorrhage, as assessed with MR-Plaque Imaging, in terms of apoB, Lp(a) levels and traditional…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the first aim, the endpoint is presence of carotid IPH on MR-Plaque imaging
at baseline. Baseline means either acquired during the hospitalization for the
index stroke or during the enrolling visit at the outpatient consultation of
the neurovascular clinic.
Secondary outcome
For the second aim, the endpoint is an ischemic, hemispheric, ipsilateral
stroke, i.e. on the same side of the carotid stenosis, on baseline brain MR-DWI.
For the third aim, the endpoint is a recurrent ischemic, hemispheric,
ipsilateral stroke in the 3-month follow-up brain MR-DWI or at any time during
the follow-up. The 3-month follow-up brain MR-DWI is conceived to detect covert
strokes, i.e. clinically asymptomatic strokes, as recurrences tend to occur
short after the first stroke.
Background summary
Atherogenic lipoproteins, also called ApoB lipoproteins, circulate in the blood
and can be trapped into the arterial wall, where they
initiate and drive atherosclerosis. All atherogenic lipoproteins are coated by
apolipoprotein (apo) B. ApoB lipoproteins include: (1) the cholesterol-rich
low-density lipoprotein (*bad cholesterol*), (2) lipoprotein(a) (Lp(a)) and (3)
the triglyceride-rich very-low density lipoprotein.1 There are pharmacological
treatments to lower ApoB blood levels. Statins lower apoB levels by lowering
low-density lipoprotein cholesterol (LDL-C) and reduce the risk of ischemic
stroke caused by atherosclerosis.2 However, even among patients achieving very
low LDL-C blood levels, there is a relevant residual risk of stroke. Factors
who can contribute to the residual risk include: (1) atherogenic Lp(a) - whose
blood levels are genetically determined and are increased by statins3 - and (2)
a hemorrhage within the carotid atherosclerotic plaque - a marker of plaque
vulnerability - as seen on Magnetic Resonance (MR) Plaque Imaging4. Recently,
we completed a prospective cohort study with 1759 participants showing that
increased Lp(a) levels were associated with an increased risk of ischemic
stroke linked to carotid atherosclerosis independent of LDL-C (manuscript
submitted). In a separate cohort study, carotid intraplaque hemorrhage was
associated with an increased risk of ischemic stroke.4 However, so far, no
study assessed - within the same cohort of patients - the link between apoB,
Lp(a) and carotid intraplaque hemorrhage with ischemic stroke. Important
questions remain yet unanswered, for instance - are patients suffering no
ischemic stroke despite carotid intraplaque hemorrhage protected by low apoB
and Lp(a) levels? Do patients who suffer ischemic stroke despite low apoB and
Lp(a) levels have more frequently carotid intraplaque hemorrhage?
Study objective
AGELESS has 3 specific aims - they all refer to patients with carotid
atherosclerosis:
1. To compare patients with and without carotid intraplaque hemorrhage, as
assessed with MR-Plaque Imaging, in terms of apoB, Lp(a) levels and traditional
cardiovascular risk factors.
2. To assess the risk of first-ever ischemic stroke in relation to apoB, Lp(a)
levels, and presence of intraplaque hemorrhage, after adjusting for traditional
cardiovascular factors.
3. To assess the risk of recurrent ischemic stroke in relation to apoB, Lp(a)
levels, and presence of intraplaque hemorrhage, after adjusting for traditional
cardiovascular factors.
Study design
A multicenter cohort study over four years - the AGELESS study.
Study burden and risks
The potential benefit of the enrolled patients is small except that these
patients will be monitored more closely than usual by MRI scans that will be
clinically evaluated for insidious pathology. Risks are smell since there are
no known risks associated with MRI acquisition.
Petersgraben 4
Basel CH-4031
CH
Petersgraben 4
Basel CH-4031
CH
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Atherosclerotic carotid stenosis NASCET 30 - 99%
- Ability to undergo a neck MR for carotid plaque imaging
- Ability to undergo a follow-up of at least 1 year
- For the prospective, longitudinal part: hemispheric ischemic stroke or
retinal ischemia ipsilateral to the carotid stenosis, with symptom onset within
24 hours.
- Written informed consent
Exclusion criteria
- Carotid stenosis due to causes other than atherosclerosis (e.g. carotid
dissection)
- Contraindication to MRI
- Lack of informed consent by patient or legal representative
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 | NL84508.041.23 |