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NCT Number: NCT04444349

Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult men and women
  • Who receive cardiovascular surgery
  • Agree to participate in the surgery and sign the informed consent form

Exclusion criteria

  • 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

Treatment and study plan

Coenzyme Q10

Drug

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.

Other names: ubiquinone

Standard Medical Therapy

Dietary Supplement

Patients only received standard medical therapy without CoQ10.

Primary outcomes

  1. C-reactive protein

    Time frame: Change from baseline of CRP in mg/L at 5 days after surgery.

    Inflammatory and endothelial blood work biomarkers

Secondary outcomes

  1. Interleukin-6

    Time frame: Change from baseline of IL-6 in pg/mL at 5 days after surgery.

    Inflammatory and endothelial blood work biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

8618801281613

Yong-feng Shao, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Beijing Anzhen Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital with Nanjing Medical University
  • West China Hospital

Registry information

Official study title

Protective Effect of Coenzyme Q10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiac and Aortic Surgery (PANDA V): a Randomized Controlled Trial

Acronym: PANDA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2020
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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