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Recruiting NCT04444349

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

No phase Interventional Cardiovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coenzyme Q10, Standard Medical Therapy.
Who it may be relevant to
Registry conditions: Cardiovascular Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Coenzyme Q10
    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.
  • Dietary supplement Standard Medical Therapy
    Patients only received standard medical therapy without CoQ10.

Primary outcome measures

  • C-reactive protein [Time frame: Change from baseline of CRP in mg/L at 5 days after surgery.]
Secondary outcome measures (1)
  • Interleukin-6 [Time frame: Change from baseline of IL-6 in pg/mL at 5 days after surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 4 centers
  • Beijing Anzhen Hospital — Beijing
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT04444349 · PANDA V

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗