Clinical trial NCT04907253: Quercetin in Coronary Artery By-pass Surgery
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Inflammation
Endothelium
Senescence
Vascular reactivity
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quercetin-associated change in surgery-associated inflammation
timeFrame: Baseline, 1 day and 4 days post-surgery
measure: Quercetin-associated change in surgery-associated marker of senescence
timeFrame: Baseline, 1 day and 4 days post-surgery
Secondary outcomes:
measure: Quercetin-dependent change in endothelium-dependent relaxation
timeFrame: During surgery
measure: Quercetin-dependent change in senescent endothelial cell load
timeFrame: During surgery
measure: Quercetin-dependent change in senescent arterial wall cell load
timeFrame: During surgery
Other outcomes:
measure: Health status at follow-up visit.
timeFrame: 8 to 12 weeks post-surgery
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Michel Carrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.