Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
NCT Number: NCT04907253
The purpose of this study is to test the anti-inflammatory and anti-senescence effects of quercetin during coronary artery by-pass graft surgery.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Montreal, Quebec, H1T 1C8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg twice daily
twice daily
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
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
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).
Time frame: Three month post-surgery
Any event that occured during the three months following surgery
Montreal Heart Institute
Other
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
Acronym: Q-CABG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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