Brief Summary
The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).
Brief Title
Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)
Completion Date
Completion Date Type
Actual
Conditions
Cardiovascular Disease and Lipoprotein(a)
Eligibility Criteria
Inclusion Criteria:
* Signed informed consent
* Established CVD defined as one of the following:
* History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
* History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
* Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
Exclusion Criteria:
- Patients currently enrolled in clinical studies with investigational drugs
* Signed informed consent
* Established CVD defined as one of the following:
* History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
* History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
* Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
Exclusion Criteria:
- Patients currently enrolled in clinical studies with investigational drugs
Inclusion Criteria
Inclusion Criteria:
* Signed informed consent
* Established CVD defined as one of the following:
* History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
* History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
* Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
* Signed informed consent
* Established CVD defined as one of the following:
* History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
* History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
* Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
Gender
All
Gender Based
false
Keywords
CVD, Lipoprotein (a),
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT03887520
Org Class
Industry
Org Full Name
Novartis
Org Study Id
CTQJ230A12001
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease
Primary Outcomes
Outcome Description
Prevalence of normal and elevated Lp(a) levels in patients with established CVD
Outcome Measure
Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD)
Outcome Time Frame
At screening
Secondary Ids
Secondary Id
2018-003786-34
Secondary Outcomes
Outcome Description
Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels
Outcome Time Frame
At screening
Outcome Measure
Lipoprotein(a) (Lp(a)) values
Outcome Description
Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country
Outcome Time Frame
At screening
Outcome Measure
Lp(a) values by region and country
Outcome Description
Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels
Outcome Time Frame
At screening
Outcome Measure
Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172