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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376738
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
M.A. de Vries, Sint Franciscus Gasthuis

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

Condition or disease
Inflammation 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.

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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Regional Activation of Leukocytes in Coronary Artery Disease
Study Start Date : July 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing coronary angiography
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376738


Locations
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Netherlands
Sint Franciscus Gasthuis
Rotterdam, Zuid-Holland, Netherlands, 3045 PM
Sint Franciscus Gasthuis
Rotterdam, Zuid-Holland, Netherlands, 3045PM
Sponsors and Collaborators
Sint Franciscus Gasthuis
Investigators
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Principal Investigator: Manuel Castro Cabezas, MD PhD Sint Franciscus Gasthuis
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Responsible Party: M.A. de Vries, PhD Student, Sint Franciscus Gasthuis
ClinicalTrials.gov Identifier: NCT02376738    
Other Study ID Numbers: REAL-CAD
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases