Primary:-To identify subjects with documented history of myocardial infarction (MI) and/or percutaneous coronary intervention (PCI) and lipoprotein(a) (Lp[a]) levels >=90 mg/dL or Lp(a) >=200 nmol/LSecondary:-Evaluate the distribution of Lp(a…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Lp(a) value.
-Lp(a) value >= 90 mg/dL or >=200 nmol/L for the subgroup of subjects with known
Lp(a) value.
Secondary outcome
-Lp(a) value.
Background summary
Cardiovascular disease remains the leading cause of death and disability
worldwide according to the World Health Organization. While lipid-lowering
therapy research has historically focused on low density lipoprotein
cholesterol to reduce Cardiovascular risk, evidence identifies elevated plasma
Lp(a) as a strong independent risk factor for ASCVD. Lp(a) has been shown to be
a risk factor for cardiovascular disease. High plasma Lp(a) concentration is
predominantly genetically defined, remains at stable levels, cannot be readily
controlled by habit modifications (diet, exercise, or other environmental
factors), and is not effectively controlled by any of the currently available
lipid reducing medications. Currently, there are no approved therapies to
lower Lp(a).
Study objective
Primary:
-To identify subjects with documented history of myocardial infarction (MI)
and/or percutaneous coronary intervention (PCI) and lipoprotein(a) (Lp[a])
levels >=90 mg/dL or Lp(a) >=200 nmol/L
Secondary:
-Evaluate the distribution of Lp(a) value in the overall subjects with
documented history of MI and/or PCI.
-Evaluate the distribution of Lp(a) value in subjects with documented history
of MI and/or PCI by demographics and regions
Study design
This is a multicenter, cross-sectional study to summarize the Lp(a)
distribution in subjects with documented history of MI and/or PCI as defined by
their medical history. Subjects will be eligible for the study if their Lp(a)
value is unknown or is known to be >= 90 mg/dL, or >= 200 nmol/L. For the subset
of subjects with known Lp(a), historical values will be used. In cases where
Lp(a) data are not available, blood sampling will be performed to analyze Lp(a)
through local laboratories. Medical history and laboratory values for Lp(a), if
applicable, will be collected retrospectively. One study visit is needed for
data collection and a blood draw to determine Lp(a), if required.
Study burden and risks
No therapy/investigational product will be administered during the course of
this study.
The patient will provide written consent in an Informed Consent Form.
For patients with a known Lp(a) value, historical values will be collected for
the study from their medical records, no further procedures or requirements
will be taken from the patient after consent.
For patients with an unknown Lp(a) value, the patient will be asked to provide
a blood sample for laboratory analysis. Once the sample has been analyzed by
the laboratory and reported, the study site will contact the patient via
telephone or other means (such as electronic communication or in-person
contact) and inform them of their Lp(a) value. No further procedures of
requirements will be taken from the patient once the follow up visit has been
conducted.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Inclusion criteria
101. Subject has provided informed consent prior to initiation of any study
specific activities/procedures.
102. Age 18 to 85 years.
103. History of ASCVD as demonstrated by either:
a) MI (presumed type 1)
And/or
b) PCI (with high-risk features) with at least 1 of the following:
- Age > 65 years
-Diabetes mellitus
- History of ischemic stroke
- History of peripheral arterial disease
- Residual stenosis >= 50%
- Multivessel PCI (ie, >= 2 vessels, including branch arteries)
See section 5.1 of the protocol.
Exclusion criteria
201. Subjects known to be currently receiving investigational drug in a
clinical study that is anticipated to last > 1 year
202. Known Lp(a) value < 90 mg/dL (if measured in mass) or < 200 nmol/L (if
measured in molar).
203. Subject has a diagnosis of end-stage renal disease or requires dialysis
204. Poorly controlled (glycated hemoglobin [HbA1c] > 10%) diabetes mellitus
(type 1 or type 2).
205. Subject is receiving or has received lipoprotein apheresis to reduce Lp(a)
within 3 months prior to enrollment.
206. Known uncontrolled or recurrent ventricular tachycardia in the past 3
months prior to enrollment.
207. Known malignancy (except non-melanoma skin cancers, cervical in situ
carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
within the last 5 years prior to enrollment.
208. Known history or evidence of clinically significant disease (eg,
respiratory, gastrointestinal, or psychiatric disease) or unstable disorder or
biomarker that, in the opinion of the investigator(s), would result in life
expectancy < 5 years.
209. Known hemorrhagic stroke.
See section 5.2 of the protocol.
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 | NL80396.028.22 |