Regional Activation of Leukocytes in Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease; Inflammation

• Registration Number: NCT02376738
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

This study aims to evaluate the role of leukocyte activation in coronary artery disease

Detailed Description

1. The primary aim of REAL CAD is to determine regional differences of leukocyte activation in different vascular beds in vivo.

2. The secondary aim is to investigate differences in leukocyte activation between diabetic and CAD subjects and patients suffering from both.

3. The third aim is to investigate the relationship between complement components, triglycerides and leukocyte activation markers in order to gain more insight into the causative processes leading to activation of leukocytes.

4. The fourth aim is to get more insight in the MBL genotypes and serum levels of CAD and/or diabetic patients and the 'healthy' groups included in our study.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Subjects scheduled to undergo a coronary catheterization
• Provide written informed consent
• Aged >18 and <75 years
• BMI < 35 kg/m2

Exclusion Criteria

• Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
• CRP > 20 mg/l
• Unstable angina pectoris
• CABG or PTCA during the last 6 months
• Alcohol use > 2 units/day
• Aberrations in kidney, liver and thyroid function
• Use of any experimental medication within 6 months of the catheterization
• The use of immunosuppressive drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the level of leukocyte activation in different vascular beds, by measuring monocyte CD11b and neutrophil CD11b and CD66b in blood obtained from the left and right coronary artery, the abdominal aorta, the femoral artery and a peripheral vein	Baseline

Secondary Outcome Measures

Name	Time	Method
To investigate the predictive value of leukocyte activation markers CD11b and CD66b in different vascular regions in the prediction of future coronary events, by measuring these markers at baseline	6 years follow-up
Investigate differences in leukocyte activation between patients with and without diabetes mellitus or coronary artery disease by comparing the level of monocyte CD11b and neutrophil CD11b and CD66b	Baseline

Trial Locations

Locations (1)

Sint Franciscus Gasthuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands