Effects of polyphenol supplementation on inflammation and coronary endothelial function in patients with documented coronary artery disease
Withdrawn
- Conditions
- 10011082atherosclerosiscoronary artery disease
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
18 years or older
& scheduled for CAG/PCI for stable angina pectoris
& with documentation of an abnormal peripheral FMD-measurement
& with signed informed consent.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Patients with unstable angina, vasospastic angina pectoris, recent myocardial infarction, valvular heart disease, clinical evidence of heart failure, left ventricular hypertrophy, uncontrolled hypertension, peripheral vascular disease, LVEF <50%, and/or significant endocrine, hepatic, renal, or inflammatory disease are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Assessment of biochemical markers of leucocyte recruitment in patients with CAD<br /><br>(MCP-1 (CCL2), CCL5, MIF, SDF-1).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Flow mediated dilatation (FMD): vasoreactivity of the brachial artery<br /><br>(measured as % change in diameter) at baseline and 3 weeks<br /><br>- Laser doppler perfusion imaging (LDPI) and iontophoresis: vasoreactivity of<br /><br>the cutaneous microvasculature at baseline and 3 weeks<br /><br>- Assessment of coronary endothelial (dys)function by an endothelial-dependent<br /><br>vasomotion test with acetylcholine (AC). The number of patients with a<br /><br>paradoxical vasoconstriction to AC is recorded in each study group.<br /><br>- Blood sampling at baseline and 3 weeks:<br /><br>Biochemical markers of inflammation (hs-CRP, IL1ß, IL6, IL10, PIGF,<br /><br>TNF* and VEGFa).<br /><br>Monocyte chemokine and adhesion molecule profile (CCL2-5, CCR1-2,<br /><br>CXCR4, LFA1): flowcytometry<br /><br>Monocyte/macrophage polarization: cell culture, qPCR) </p><br>