Clinical trial NCT02376738: Regional Activation of Leukocytes in Coronary Artery Disease
Official title: Regional Activation of Leukocytes in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Coronary Artery Disease
Lead sponsor: Sint Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary angiography

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline
Secondary outcomes:
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 6 years follow-up
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
state: Zuid-Holland
Study officials:
affiliation: Sint Franciscus Gasthuis
name: Manuel Castro Cabezas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: