Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01319110
First received: March 18, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Sudden Cardiac Arrest
Dietary Supplement: Coenzyme Q10
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Prevalence of low serum CoQ10 levels in Cardiac Arrest Patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.


Secondary Outcome Measures:
  • Comparison of serum CoQ10 levels randomized to supplementation vs. placebo [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.


Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoenzymeQ10
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.
Dietary Supplement: Coenzyme Q10
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.
Other Name: Ubiquinone
Placebo Comparator: Placebo
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
Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.

Detailed Description:

Cardiac arrest (CA) occurs in nearly 350,000 patients in the U.S. each year with an estimated mortality of 60% in those surviving the initial arrest. Moreover, the overall prognosis for survivors is often limited by neurologic injury. Two randomized control trials (RCTs) have demonstrated that therapeutic hypothermia (TH) after CA improves survival and reduces neurologic morbidity. As a result of these studies, TH has become the standard of care in post-CA patients. The mechanism of action for TH is hypothesized to be a reduction in cerebral oxygen consumption that occurs following an ischemia-reperfusion injury. Another similar potential target following ischemia-reperfusion injury is mitochondrial function in the injured brain cells and attenuation of potentially damaging oxygen-free radicals. Specifically, optimizing mitochondrial function and reducing oxygen free radicals may enhance cellular function and mitigate cellular injury thereby leading to improved neurologic outcomes. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been found to have neuroprotective effects in various neurodegenerative disorders such as Parkinson's disease and Huntington's disease. Whether CoQ10 can provide neuroprotection in acute ischemia-reperfusion injury remains less clear, but has been recognized by the American Heart Association as a potentially promising neuroprotective agent. We hypothesize that the administration of exogenous CoQ10 will raise serum concentrations of CoQ10 and as such may mitigate the adverse effects of the post-CA ischemia-reperfusion injury on the brain by optimizing mitochondrial function and reducing oxygen-free radicals. We support this hypothesis by the following:

  1. Ischemia-reperfusion injury disrupts normal mitochondrial function and increases O2 free radicals.
  2. CoQ10 has been found to attenuate the effects of ischemia-reperfusion injury through optimizing mitochondrial function and mitigation of cellular apoptosis.
  3. CoQ10 has neuroprotective effects in other neurodegenerative disorders.
  4. Our group has unpublished preliminary data showing low CoQ10 levels in a majority of patients with septic shock, and that lower CoQ10 levels are significantly associated with multiple markers of the inflammatory cascade.
  5. A pilot human trial in post-CA patients demonstrated a reduction in mortality and trend toward reduction in neurologic morbidity.

To test our hypothesis, we propose the following pilot study as proof of concept in preparation for a larger multicenter trial powered toward neurologic outcome and mortality. This pilot study will allow for a more informed power analysis for a larger trial, provide proof of concept for enrollment and administration of therapy, examine the time-frame for drug absorption into serum, and evaluate for tolerability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (age > 18 years)
  2. Comatose after CA with subsequent return of spontaneous circulation

Exclusion Criteria:

  1. Comatose status prior to CA
  2. CoQ10 therapy within one month prior to CA
  3. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319110

Contacts
Contact: Michael N Cocchi, MD 617-754-2295 mcocchi@bidmc.harvard.edu
Contact: Michael W Donnino, MD 617-754-2295 mdonnino@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael N Cocchi, MD    617-754-2295    mcocchi@bidmc.harvard.edu   
Contact: Michael W Donnino, MD    617-754-2295    mdonnino@bidmc.harvard.edu   
Principal Investigator: Michael N Cocchi, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Michael N Cocchi, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael N. Cocchi, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01319110     History of Changes
Other Study ID Numbers: 2010P-000362
Study First Received: March 18, 2011
Last Updated: March 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Cardiac Arrest
Post Cardiac Arrest
CoQ10
Ubiquinone
Post Arrest

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Cardiovascular Diseases
Death
Death, Sudden
Heart Diseases
Pathologic Processes
Coenzyme Q10
Ubiquinone
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 30, 2014