Quercetin in Coronary Artery By-pass Surgery

Coronary Artery Disease Clinical Trial

— Q-CABG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04907253
• Other study ID #: 2021-2761
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 4, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Quercetin
500 mg twice daily
• Placebo
twice daily

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health status at follow-up visit.	During the follow-up visit, routine patient questioning will be performed and medical file will be reviewed for noticeable change in health status.	8 to 12 weeks post-surgery
Primary	Quercetin-associated change in surgery-associated inflammation	Circulating blood levels of hs-CRP (mg/L) will be measured.	Baseline, 1 day and 4 days post-surgery
Primary	Quercetin-associated change in surgery-associated marker of senescence	Circulating blood levels of ANGPTL2 (ng/L) will be measured.	Baseline, 1 day and 4 days post-surgery
Secondary	Quercetin-dependent change in endothelium-dependent relaxation	When available, a discarded segment of the mammary artery will be collected at the end of the cardiac surgery.; 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 two parameters, the vascular sensitivity to acetylcholine (µM) and the maximal relaxation induced by acetylcholine (% of relaxation).	During surgery
Secondary	Quercetin-dependent change in senescent endothelial cell load	When available, a discarded segment of the mammary artery will be collected at the end of the cardiac surgery.; One portion of the segment will be used to isolate arterial wall cell nuclei for single nuclei mRNA sequencing. Senescence is assessed by expression levels of p21 mRNA, p16 mRNA and ANGPTL2 mRNA.	During surgery
Secondary	Quercetin-dependent change in senescent arterial wall cell load	When available, a discarded segment of the mammary artery will be collected at the end of the cardiac surgery.; One portion of the segment will be stored at -80oC for bulk mRNA sequencing. Arterial wall senescence will be assessed by expression levels of p21 mRNA, p16 mRNA and ANGPTL2 mRNA.	During surgery