The objective is to assess whether individuals identified with elevated Lp(a) through familial cascade screening have an increased presence of coronary atherosclerotic plaque compared to matched controls with normal Lp(a).
ID
Source
Brief title
Condition
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the presence of coronary plaque measured via CCTA.
Secondary outcome
Secondary parameters include the presence of obstructive stenosis, total
coronary plaque volumes, calcified and non-calcified plaque volumes,
low-attenuation plaque, pericoronary adipose tissue attenuation, high risk
plaque features, and the CAD-RADS classification.
Background summary
This study aims to address the current knowledge gap regarding the relationship
between elevated Lipoprotein(a) (Lp(a)) and subclinical atherosclerosis in
patients that have been identi-fied through familial Lp(a) cascade screening.
Despite Lp(a) being a known genetic risk factor for ASCVD, the clinical
significance of detecting elevated Lp(a) through familial cascade screening,
particularly among individuals in primary prevention, is unclear.
Study objective
The objective is to assess whether individuals identified with elevated Lp(a)
through familial cascade screening have an increased presence of coronary
atherosclerotic plaque compared to matched controls with normal Lp(a).
Study design
This is an observational cohort study comparing two groups: individuals
identified through familial cascade screening with elevated Lp(a) and matched
controls with normal Lp(a) levels. The study will use CCTA and CAC scoring to
assess subclinical atherosclerosis in both groups.
Study burden and risks
Participants will undergo medical history taking, physical examination, blood
sampling, and CCTA imaging, which involves exposure to a small amount of
radiation and the use of contrast agents. These procedures are associated with
minimal discomfort. The benefits include early detection of subclinical
atherosclerosis, enabling timely preventive measures as proposed by the current
CVRM guidelines. The use of contrast media poses a low risk of nephrotoxicity,
mitigated by excluding participants with renal insufficiency. Participants may
also experience anxiety from potential incidental findings, but stand to gain
more insight into their cardiovascular risk profile.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study in the elevated Lp(a)
subgroup, a subject must meet all of the following criteria:
• Man or woman >=50 years of age;
• Lp(a) level >= 150 nmol/L;
• Identified as having elevated Lp(a) through Lp(a) family cascade screening at
the Amsterdam UMC Vascular Medicine outpatient clinic;
• Able and willing to provide informed consent;
• Able to comply with study requirements.
In order to be eligible to participate in this study in the control subgroup, a
subject must meet all of the following criteria:
• Man or woman >=50 years of age;
• Lp(a) level < 50 nmol/L;
• Participated in Lp(a) family cascade screening at the Amsterdam UMC Vascular
Medicine outpatient clinic as family member of index patient;
• Able and willing to provide informed consent;
• Able to comply with study requirements.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study (both subgroups):
• Renal insufficiency, defined as eGFR < 30 ml/min
• History of ASCVD (acute coronary syndrome, history of myocardial infarction,
stable or unstable angina pectoris or coronary or other arterial
revascularization, stroke, transient ischemic attack or peripheral artery
disease including aortic aneurysm, all of atherosclerotic origin)
• History of atrial fibrillation
• Prior and current use of statins
• Any other treatment or clinically relevant condition that could interfere
with the conduct or interpretation of the study in the opinion of the
investigator
• Unable or unwilling to provide informed consent
• Unable to comply with study requirements.
Design
Recruitment
Medical products/devices used
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 | NL88112.018.24 |