Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

NCT01319110 | Completed Phase 2 Results DMC

• 1 other identifier: 2010P000362
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will perform a prospective trial with the primary endpoint of describing the prevalence of low serum CoQ10 levels. Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of post-CA patients with the secondary endpoint of comparing CoQ10 levels among those randomized to CoQ10 supplementation vs placebo.

Conditions

Cardiac Arrest; Sudden Cardiac Arrest

Keywords

Cardiac Arrest; Post Cardiac Arrest; CoQ10; Ubiquinone; Post Arrest

Outcome Measures

Primary Outcomes (1)

• Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients

  The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.

  Baseline

Secondary Outcomes (1)

• Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo

  1 year

Study Arms (2)

CoenzymeQ10

EXPERIMENTAL

Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.

Drug: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.

Dietary Supplement: Placebo

Interventions

Coenzyme Q10 DRUG

Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.

Also known as: Ubiquinone

CoenzymeQ10

Placebo DIETARY_SUPPLEMENT

Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \> 18 years)
• Comatose after CA with subsequent return of spontaneous circulation

You may not qualify if:

• Comatose status prior to CA
• CoQ10 therapy within one month prior to CA
• Pregnancy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Beth Israel Deaconess Medical Center Cardiac Arrest Center

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Dr. Michael Cocchi
• Organization: Beth Israel Deaconess Medical Center

mcocchi@bidmc.harvard.edu

Study Officials

• Michael N Cocchi, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: February 1, 2011
• Primary Completion: December 31, 2011
• Study Completion: December 31, 2011
• Last Updated: July 31, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-07

Locations

US (1)