The inflammatory response of monocytes and neutrophils to Crystals after Low dose colchicine in patients with coronary artery disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* Have suffered from type 1 myocardial infarction
* Have been clinically stable for at least three months
* Provided written informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Age below 18 years or above 80 years
* Use of CYP3A4 or P-glycoprotein inhibitors such as macrolids (claritromycin
and erytromycin), ciclosporin, ketoconazol, itraconazol, voriconazol, HIV
protease inhibitors, calciumchannel antagonists such as verapamil and diltiazem
* Women who are pregnant, breast feeding or may be considering pregnancy during
the study period or six month after the end of study participation
* Male patients who may be considering conceiving during the study period or
before six months after the end of study participation
* Have renal impairment as evidenced by a serum creatinine >150 *mol/l or eGFR
<50mL/min/1.73m2)
* Have an elevated inflammatory profile as evidenced by a hsCRP >10mg/l in
order to exclude patients with intercurrent (subclinical) infections
* Have a moderate to severe hepatic disease
* Suffer from pre-existing chronic gastro-intestinal complaints which might
obscure signs of colchicine toxicity
* Malignant disease in past five years or any medical condition that could
interfere with the conduct of the study in the opinion of the investigator.
* Chronic or recent (<1 month) infections and/or clinical signs of acute
infection
* Suffering from auto-immune / inflammatory diseases
* Chronic use of immunosuppressants or anti-inflammatory drugs, including
colchicine
* A history of haematological malignant disease
* Recent hospital admission or surgery with general anaesthesia (<3 months)
* Previous vaccination within 1 month prior to study entry
* Inability or unwillingness to comply with the protocol requirements, or
deemed by investigator to be unfit for the study.
* Are currently enrolled in a competing trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in inflammatory cytokine release of monocytes and neutrophils,<br /><br>stimulated with MSU crystals, isolated before versus after treatment with<br /><br>colchicine 0.5mg during one month compared to placebo</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess whether hsCRP change in serum correlates with change in cytokine<br /><br>release by monocytes and neutrophils stimulated with MSU crystals, isolated<br /><br>from patients with chronic coronary artery disease after colchicine 0.5mg daily<br /><br>during one month compared to placebo<br /><br><br /><br>- To assess changes of RNA expression in CD14+ monocytes, isolated from<br /><br>patients with chronic coronary artery disease after colchicine 0.5mg daily<br /><br>during one month, compared to placebo</p><br>