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

February 25, 2015 updated by: M.A. de Vries, Sint Franciscus Gasthuis
This study aims to evaluate the role of leukocyte activation in coronary artery disease

Study Overview

Status

Completed

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: 6 years follow-up
6 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sint Franciscus Gasthuis

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • REAL-CAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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