Quercetin in Coronary Artery By-pass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2025-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute

Study Groups

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Quercetin

Patients receiving 500 mg quercetin twice daily

Group Type ACTIVE_COMPARATOR

Quercetin

Intervention Type DRUG

500 mg twice daily

Placebo

Patients receiving placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice daily

Interventions

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Quercetin

500 mg twice daily

Intervention Type DRUG

Placebo

twice daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No