Quercetin in Coronary Artery By-pass Surgery (Q-CABG)

April 13, 2026 updated by: Montreal Heart Institute

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

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quercetin
Patients receiving 500 mg quercetin twice daily
500 mg twice daily
Placebo Comparator: Placebo
Patients receiving placebo twice daily
twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quercetin-associated Change in Surgery-associated Inflammation
Time Frame: 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
Baseline, 1 day and 4 days post-surgery
Quercetin-associated Change in Surgery-associated Marker of Senescence
Time Frame: 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
Baseline, 1 day and 4 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation
Time Frame: During surgery

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).

During surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Follow-up
Time Frame: Three month post-surgery
Any event that occured during the three months following surgery
Three month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michel Carrier, MD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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