Étude randomisée contrôlée Par Placebo de Phase II Visant à Mesurer l'Effet Anti-inflammatoire et Anti-sénescence de la quercétine Lors d'Une Chirurgie Cardiaque
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quercetin-associated change in surgery-associated marker of senescence
研究概览
简要总结
The purpose of this study is to test the anti-inflammatory and anti-senescence effects of quercetin during coronary artery by-pass graft surgery.
详细描述
After being informed about the study and the potential risk, all patients giving written informed consent will be randomized in a double-blind manner (participant and investigators) on 1:1 ratio to receive quercetin (500 mg twice daily) or placebo (twice daily) starting 2 days before a coronary artery by-pass graft surgery and for the duration of their hospitalization but up to 10 days (i.e. up to 7 days post-surgery). Blood (5 ml) will be collected the first morning after recruitment (t-1), 24h post-surgery (t1), day 4 post-surgery (t2) and day of hospital discharge for blood analyses. During the surgery, if a discarded segment of mammary artery is available, it will be collected for laboratory work. Health status will be assessed during the follow-up visit 8 to 12 weeks post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be able to speak French or English;
- •to be able to give free and enlighten consent;
- •be hospitalized and waiting for a cardiac surgery of revascularization;
- •to have had a myocardial infarction (MI) within the past 30 days or to be in a state of stable angina before the surgery.
排除标准
- •to be in a stable state without MI in the last 30 days;
- •have a cardiac surgery concomitant to the cardiac surgery of revascularization;
- •have an infection in the last 30 days;
- •to have renal insufficiency (GFR less than 30);
- •to have a liver disease (AST, ALT or bilirubin ˃ 2X normal values);
- •to have a known cirrhosis;
- •to have a past history of breast cancer or other tumors estrogen-dependent;
- •to be intolerant to flavonoids, niacine or ascorbic acid;
- •take quinolone;
- •need for a quinolone during post-op;
- •not being able to give a free and enlighten consent;
- •not being able to speak French of English;
- •take quercetin as a supplement.
研究组 & 干预措施
Placebo
Patients receiving placebo twice daily
干预措施: Placebo (Drug)
Quercetin
Patients receiving 500 mg quercetin twice daily
干预措施: Quercetin (Drug)
结局指标
主要结局
Quercetin-associated change in surgery-associated marker of senescence
时间窗: Baseline, 1 day and 4 days post-surgery
Circulating blood levels of ANGPTL2 (ng/L) will be measured.
Quercetin-associated change in surgery-associated inflammation
时间窗: Baseline, 1 day and 4 days post-surgery
Circulating blood levels of hs-CRP (mg/L) will be measured.
Quercetin-associated Change in Surgery-associated Inflammation
时间窗: Baseline, 1 day and 4 days post-surgery
Circulating blood levels of hs-CRP (mg/L) will be measured as well as a panel of circulating inflammatory markers in a subgroup of patients at day 5 post-surgery
Quercetin-associated Change in Surgery-associated Marker of Senescence
时间窗: Baseline, 1 day and 4 days post-surgery
Circulating blood levels of ANGPTL2 (ng/L) will be measured in addition to additional circulating markers of inflammation in a sub-group of patients at day 4 post-surgery
次要结局
- Quercetin-dependent change in endothelium-dependent relaxation(During surgery)
- Quercetin-dependent change in senescent endothelial cell load(During surgery)
- Quercetin-dependent change in senescent arterial wall cell load(During surgery)
- Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation(During surgery)