FindTrial
Sign In

Effects of polyphenol supplementation on inflammation and coronary endothelial function in patients with documented coronary artery disease

Effects of polyphenol supplementation on inflammation and coronary endothelial function in patients with documented coronary artery disease - PENSION

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40828
Enrollment
30
Registered
2014-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis coronary artery disease

Interventions

The intervention group will be treated with a dietary supplement Polyphenols (Vinitrox), while the other group receives a placebo. In addition to the dietary supplement/placebo, all patients undergo

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Assessment of biochemical markers of leucocyte recruitment in patients with CAD (MCP-1 (CCL2), CCL5, MIF, SDF-1).—

Secondary

MeasureTime frame
Secondary endpoints: - Flow mediated dilatation (FMD): vasoreactivity of the brachial artery (measured as % change in diameter) at baseline and 3 weeks - Laser doppler perfusion imaging (LDPI) and iontophoresis: vasoreactivity of the cutaneous microvasculature at baseline and 3 weeks - Assessment of coronary endothelial (dys)function by an endothelial-dependent vasomotion test with acetylcholine (AC). The number of patients with a paradoxical vasoconstriction to AC is recorded in each study group. - Blood sampling at baseline and 3 weeks: Biochemical markers of inflammation (hs-CRP, IL1ß, IL6, IL10, PIGF, TNF* and VEGFa). Monocyte chemokine and adhesion molecule profile (CCL2-5, CCR1-2, CXCR4, LFA1): flowcytometry Monocyte/macrophage polarization: cell culture, qPCR)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)