Lp-PLA2 and Coronary Atherosclerosis in Humans (AIM 1 and II)
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|ClinicalTrials.gov Identifier: NCT01557088|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Atherosclerosis Endothelial Dysfunction||Other: Blood sampling from the Coronary Sinus and Aorta Procedure: Intravascular Ultrasound of the coronary artery.||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
- Other: Blood sampling from the Coronary Sinus and Aorta
Blood samples will be obtained from the aorta and the coronary sinus during the clinically scheduled angiogram and endothelial function testing.
- Procedure: Intravascular Ultrasound of the coronary artery.
Intravascular Ultrasound will be completed for those subjects testing positive for coronary endothelial dysfunction during a clinically scheduled angiogram and endothelial function testing.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557088
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, MD||Mayo Clinic|