Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)
PANDA
Protective Effect of Coenzyme Q10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiac and Aortic Surgery (PANDA V): a Randomized Controlled Trial
1 other identifier
interventional
500
1 country
4
Brief Summary
Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 27, 2024
November 1, 2024
4.9 years
June 20, 2020
November 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C-reactive protein
Inflammatory and endothelial blood work biomarkers
Change from baseline of CRP in mg/L at 5 days after surgery.
Secondary Outcomes (1)
Interleukin-6
Change from baseline of IL-6 in pg/mL at 5 days after surgery.
Study Arms (2)
Coenzyme Q10 group
EXPERIMENTALParticipants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).
Control
SHAM COMPARATORpatients only receive standard medical therapy.
Interventions
Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.
Patients only received standard medical therapy without CoQ10.
Eligibility Criteria
You may qualify if:
- Adult men and women
- Who receive cardiovascular surgery
- Agree to participate in the surgery and sign the informed consent form
You may not qualify if:
- Pregnant or planning on getting pregnant during the study
- Contain a minimum of 2 traits of metabolic syndrome
- Refused to participate in the surgery and refused informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing Medical Universitylead
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Beijing Anzhen Hospitalcollaborator
- West China Hospitalcollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
Study Sites (4)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator of Cardio-Thoracic Surgery
Study Record Dates
First Submitted
June 20, 2020
First Posted
June 23, 2020
Study Start
February 1, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share