Lp-PLA2 and Coronary Atherosclerosis in Humans
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 08-008161
NCT ID: NCT01557088
Sponsor Protocol Number: 08-008161
About this study
The majority of the acute coronary events are caused by coronary artery segments with minimal luminal disease, but with potentially significant vascular wall inflammation and oxidative stress leading to plaque vulnerability. It has become apparent that an initial injury at the endothelial surface, is the primary site of the mechanisms involved and a role for vascular inflammation and the interaction with oxidative stress continues to emerge. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall inflammation that circulates in the blood bound to both low density (LDL) and high density (HDL) lipoprotein and promotes vascular inflammation. Circulating levels of Lp-PLA2 mass and activity are an independent risk factor for cardiovascular events. Recent studies, demonstrating that Lp-PLA2 is also associated with coronary endothelial dysfunction. However, the relationship between Lp-PLA2 and early atherosclerotic changes in the coronary arteries, and the contribution of lipoprotein binding to the deleterious potential of Lp- PLA2 have not been elucidated. Our working hypothesis is that the endogenous local activation of the Lp-PLA2 pathway plays an integral role in early coronary atherosclerosis and contributes to the mechanism of coronary endothelial dysfunction and the structural and mechanical properties reflecting plaque vulnerability. Thus, the current application will characterize prospectively the correlation between the functional, mechanical, and structural vascular wall properties, and the systemic as well as the coronary activity of the Lp-PLA2 pathway.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Study closed to enrollment
Inclusion Criteria:
- Patients undergoing coronary angiography including endothelial function testing
- male and female
- age 18 up to age 85
Exclusion Criteria:
- Heart failure with ejection fraction less that 40%
- unstable angina
- myocardial infarction or angioplasty within 6 months prior to entry into the study
- use of investigational agents within 1 month of entry into the study
- patients who require treatment with positive inotropic agents other than digoxin during the study
- patients with cerebrovascular accident within 6 months prior to entry into the study
- significant endocrine, hepatic or renal disorders
- local or systemic infectious disease within 4 weeks prior to entry into study
- pregnancy or lactation (women of child-bearing age will have a pregnancy test prior to angiogram)
- mental instability
- federal medical center inmates
- hemoglobin less than 12 mg/dL
- severe asthma
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Amir Lerman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available