Skip to main content
OpenTrials
Completed

NCT Number: NCT02376738

Regional Activation of Leukocytes in Coronary Artery Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sint Franciscus Gasthuis, Rotterdam, South Holland, Netherlands

Loading trial locations.

About this study

  • The primary aim of REAL CAD is to determine regional differences of leukocyte activation in different vascular beds in vivo.
  • The secondary aim is to investigate differences in leukocyte activation between diabetic and CAD subjects and patients suffering from both.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Baseline

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: 6 years follow-up

Sponsors and collaborators

Lead sponsor

Sint Franciscus Gasthuis

Other

Registry information

Acronym: REAL-CAD

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.