InflammationREAL-CADNCT02376738
Regional Activation of Leukocytes in Coronary Artery Disease
An observational study of Inflammation and Coronary Artery Disease, run by Sint Franciscus Gasthuis at 2 sites in Netherlands.
Trial summary
This study aims to evaluate the role of leukocyte activation in coronary artery disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Coronary Artery Disease
- How many people
- 97 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jul 2007to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing coronary angiography
Who may be able to join
- Subjects scheduled to undergo a coronary catheterization
- Provide written informed consent
- Aged >18 and <75 years
- BMI < 35 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045PM
About this study
This study aims to evaluate the role of leukocyte activation in coronary artery disease
Read the detailed description
- 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.
- Conditions
- Inflammation, Coronary Artery Disease
- Medical subject headings
- Inflammation, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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
Measured: 6 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.A. de Vries, Sint Franciscus Gasthuis
- Investigators
- Manuel Castro Cabezas, MD PhD, Principal investigator, Sint Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376738
- Sponsor's protocol ID
- REAL-CAD
- Acronym
- REAL-CAD
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Activation of Leukocytes in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02376738
- Acronym / sponsor ID
- REAL-CAD / REAL-CAD
- Conditions
- Inflammation, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sint Franciscus GasthuisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the role of leukocyte activation in coronary artery disease
Detailed description
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary angiography
Key inclusion criteria (4 listed)
- Subjects scheduled to undergo a coronary catheterization
- Provide written informed consent
- Aged >18 and <75 years
- BMI < 35 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Castro Cabezas, MD PhD principal investigator
Sint Franciscus Gasthuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Coronary Artery Disease, run by Sint Franciscus Gasthuis at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.