- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01557088
Lp-PLA2 and Coronary Atherosclerosis in Humans (AIM 1 and II)
Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans
Study Overview
Status
Conditions
Detailed Description
Aim I: Hypothesis: The extent of endothelial dysfunction will correlate with production of Lp-PLA2 and oxidative stress and correlates with the tissue characteristics of plaque vulnerability. The investigators will define the systemic and coronary gradient and production of markers of inflammation and oxidative stress and the presence of coronary endothelial dysfunction in patients with early coronary atherosclerosis.
Aim II: Hypothesis: The distribution of Lp-PLA2 on the LDL is associated with greater coronary endothelial dysfunction and correlates with the degree coronary atherosclerosis and plaque vulnerability. The investigators will define the distribution of Lp-PLA2 in patients with early coronary atherosclerosis and endothelial dysfunction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lp-PLA2 Assessment
Time Frame: baseline endothelial function assessment 6 months
|
AIM 1: To assess the relationship between the 3 inflammatory measures of the Lp-PLA2 pathway (Lp-PLA2 mass, Lp-PLA2 activity and LysoPC) with endothelial function (as measured by the percent change in CAD (coronary artery disease) [Ach] and by the length of segments with endothelial dysfunction and plaque vulnerability (as measured by the necrotic core percent volume).
AIM II: To assess the association between the percent of Lp-PLA2 residing on LDL and endothelial function (again measured by percent change in CAD [Ach], percent change in CBF (coronary blood flow)[Ach], and the length of endothelial dysfunction).
|
baseline endothelial function assessment 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-008161
- 5R01HL92954-01A1-05 (Other Grant/Funding Number: US NIH Grant)
- 1R01 AG31750-01A2-04 (Other Grant/Funding Number: NIA)
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