Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quercetin | Active Comparator | Patients receiving 500 mg quercetin twice daily |
|
| Placebo | Placebo Comparator | Patients receiving placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin | Drug | 500 mg twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline, 1 day and 4 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Follow-up | Any event that occured during the three months following surgery | Three month post-surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michel Carrier, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30745045 | Background | 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. | |
| 40375481 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
coronary unit patients waiting for CABG surgery
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | receive placebo BID |
| FG001 | Quercetin | reveive quercetin 500mg twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo BID |
| BG001 | Quercetin | Quercetin 500mg BID |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Men and women treated with quercetin or placebo starting 2 days before surgery | Posted | Mean | Standard Deviation | mg/L | Baseline, 1 day and 4 days post-surgery |
|
3 months
death, recurrent angina, graft failure
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | receive placebo twice a day | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Eric Thorin | Montreal Heart Institute | 514-376-3330 | 3589 | eric.thorin@umontreal.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2020 | Jun 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2023 | Jun 26, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011794 | Quercetin |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
Not provided
Randomized, double-blind, placebo-controlled
Not provided
Not provided
Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute
| Drug |
twice daily |
|
| During surgery |
| 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. |
| 34746258 | Derived | 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. |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Inflammatory status (hs-CRP values) | High reactive C-reactive Protein Levels are measured before the surgery in the blood of all patients | Mean | Standard Deviation | mg/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Men and women treated with quercetin or placebo starting 2 days before surgery | Posted | Mean | Standard Error | ng/L | Baseline, 1 day and 4 days post-surgery |
|
|
|
| Secondary | 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). | Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation | Posted | Median | Full Range | nM | During surgery | artery | artery |
|
|
|
| Other Pre-specified | Patient Follow-up | Any event that occured during the three months following surgery | No event (death, recurrent angina, graft failure) occured after surgery during the following 3 months | Posted | Three month post-surgery | Events | Events |
|
|
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Quercetin | receive quercetin twice a day | 0 | 47 | 0 | 47 | 0 | 47 |
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| t1 women |
|
|
| t4 women |
|
|
| baseline men |
|
|
| t1 men |
|
|
| t4 men |
|
|