- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907253
Quercetin in Coronary Artery By-pass Surgery (Q-CABG)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Michel Carrier, MD, Montreal Heart Institute
Publications and helpful links
General Publications
- Noly PE, Labbe P, Thorin-Trescases N, Fortier A, Nguyen A, Thorin E, Carrier M. Reduction of plasma angiopoietin-like 2 after cardiac surgery is related to tissue inflammation and senescence status of patients. J Thorac Cardiovasc Surg. 2019 Sep;158(3):792-802.e5. doi: 10.1016/j.jtcvs.2018.12.047. Epub 2019 Jan 8.
- Dagher O, Mury P, Noly PE, Fortier A, Lettre G, Thorin E, Carrier M. Design of a Randomized Placebo-Controlled Trial to Evaluate the Anti-inflammatory and Senolytic Effects of Quercetin in Patients Undergoing Coronary Artery Bypass Graft Surgery. Front Cardiovasc Med. 2021 Oct 20;8:741542. doi: 10.3389/fcvm.2021.741542. eCollection 2021.
- Mury P, Dagher O, Fortier A, Diaz A, Lamarche Y, Noly PE, Ibrahim M, Page P, Demers P, Bouchard D, Bernier PL, Poirier N, Moss E, Durrleman N, Jeanmart H, Pellerin M, Lettre G, Thorin-Trescases N, Carrier M, Thorin E. Quercetin Reduces Vascular Senescence and Inflammation in Symptomatic Male but Not Female Coronary Artery Disease Patients. Aging Cell. 2025 Aug;24(8):e70108. doi: 10.1111/acel.70108. Epub 2025 May 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Pathological Conditions, Signs and Symptoms
- Inflammation
- Coronary Artery Disease
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pyrans
- Benzopyrans
- Flavonols
- Flavonoids
- Chromones
- Quercetin
Other Study ID Numbers
- 2021-2761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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