search
Back to results

Quercetin in Coronary Artery By-pass Surgery (Q-CABG)

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Quercetin
Placebo
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Inflammation, Endothelium, Senescence, Vascular reactivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quercetin

Placebo

Arm Description

Patients receiving 500 mg quercetin twice daily

Patients receiving placebo twice daily

Outcomes

Primary Outcome Measures

Quercetin-associated change in surgery-associated inflammation
Circulating blood levels of hs-CRP (mg/L) will be measured.
Quercetin-associated change in surgery-associated marker of senescence
Circulating blood levels of ANGPTL2 (ng/L) will be measured.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
May 12, 2021
Last Updated
June 1, 2023
Sponsor
Montreal Heart Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04907253
Brief Title
Quercetin in Coronary Artery By-pass Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Inflammation, Endothelium, Senescence, Vascular reactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quercetin
Arm Type
Active Comparator
Arm Description
Patients receiving 500 mg quercetin twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Quercetin
Intervention Description
500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Quercetin-associated change in surgery-associated inflammation
Description
Circulating blood levels of hs-CRP (mg/L) will be measured.
Time Frame
Baseline, 1 day and 4 days post-surgery
Title
Quercetin-associated change in surgery-associated marker of senescence
Description
Circulating blood levels of ANGPTL2 (ng/L) will be measured.
Time Frame
Baseline, 1 day and 4 days post-surgery
Secondary Outcome Measure Information:
Title
Quercetin-dependent change in endothelium-dependent relaxation
Description
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).
Time Frame
During surgery
Title
Quercetin-dependent change in senescent endothelial cell load
Description
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.
Time Frame
During surgery
Title
Quercetin-dependent change in senescent arterial wall cell load
Description
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.
Time Frame
During surgery
Other Pre-specified Outcome Measures:
Title
Health status at follow-up visit.
Description
During the follow-up visit, routine patient questioning will be performed and medical file will be reviewed for noticeable change in health status.
Time Frame
8 to 12 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Carrier, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30745045
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.
Results Reference
background
PubMed Identifier
34746258
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.
Results Reference
derived

Learn more about this trial

Quercetin in Coronary Artery By-pass Surgery

We'll reach out to this number within 24 hrs