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

NCT ID: NCT04444349

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Coenzyme Q10 group

Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type 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.

Control

patients only receive standard medical therapy.

Group Type SHAM_COMPARATOR

Standard Medical Therapy

Intervention Type DIETARY_SUPPLEMENT

Patients only received standard medical therapy without CoQ10.

Interventions

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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.

Intervention Type DRUG

Standard Medical Therapy

Patients only received standard medical therapy without CoQ10.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ubiquinone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Investigator of Cardio-Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

8618801281613

Yong-feng Shao, MD

Role: CONTACT

02568303101

Facility Contacts

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SI-CHONG Qian, MD

Role: primary

HONG-JIA Zhang

Role: backup

Si-chong Qian

Role: backup

YING-YUAN Zhang, MD

Role: primary

Ying-yuan Zhang, MD

Role: backup

8613662378847

Ying-yuan Zhang, MD

Role: backup

Hong Liu, MD

Role: primary

18801281613

Hong MD, MD

Role: backup

Hong Liu, MD

Role: backup

Hong-hua Yue, MD

Role: primary

Zhong Wu, MD

Role: backup

Hong-hua Yue, MD

Role: backup

Other Identifiers

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PANDA V

Identifier Type: -

Identifier Source: org_study_id

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