Regional Activation of Leukocytes in Coronary Artery Disease (REAL-CAD)

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Inflammation

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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
      • Sint Franciscus Gasthuis
    • Rotterdam, Zuid-Holland, Netherlands, 3045PM
      • Sint Franciscus Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing coronary angiography

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sint Franciscus Gasthuis
• Investigators: Principal Investigator: Manuel Castro Cabezas, MD PhD, Sint Franciscus Gasthuis

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
• Other Study ID Numbers: REAL-CAD