Quercetin in Coronary Artery By-pass Surgery

Montreal Heart Institute100 enrolled

Overview

The purpose of this study is to test the anti-inflammatory and anti-senescence effects of quercetin during coronary artery by-pass graft surgery.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

QuercetinDRUG

500 mg twice daily

PlaceboDRUG

twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Quercetin-associated Change in Surgery-associated Inflammation

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

Time frame: Baseline, 1 day and 4 days post-surgery

Quercetin-associated Change in Surgery-associated Marker of Senescence

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

Time frame: Baseline, 1 day and 4 days post-surgery

Secondary Outcomes

Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation

A discarded segment of the mammary artery will be collected at the end of the cardiac surgery when available. One portion of the segment will be used to study the endothelium-dependent relaxation ex vivo. Segments will be mounted on a wire myograph. After an equilibration period, it will be pre-contracted with U46619 (0.1 µM): when the pre-contraction is stable, a cumulative dose-response curve to acetylcholine is built to induce an endothelium-dependent relaxation. Relaxation will be determined by the vascular sensitivity to acetylcholine (nM). IMPORTANT: at completion of the study, the analysis revealed that during the surgery, only 34 arterial segments from patients in the quercetin group and 44 segments from patients in the placebo group were made available by the surgeon. Therefore, only these 78 arterial segments were analyzed for this outcome measure of the ITT population (n=97).

Time frame: During surgery

Data from ClinicalTrials.gov

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