Regional Activation of Leukocytes in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— REAL-CAD  

Official title:

Regional Activation of Leukocytes in Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376738
• Other study ID #: REAL-CAD
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: February 25, 2015
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2015
• Source: Sint Franciscus Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Myocardial Ischemia

Locations

Country	Name	City	State
Netherlands	Sint Franciscus Gasthuis	Rotterdam	Zuid-Holland
Netherlands	Sint Franciscus Gasthuis	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Sint Franciscus Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No