Lack of funding and low accrual.
Effects of Low Level Carbon Monoxide Preconditioning on Human Mitochondrial Biogenesis in Aortic Valve Surgery Patients
Sponsor study identifier
interventional
1
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
March 2016
Actual (reported)This study will test if inhalation of Carbon Monoxide (CO) will increase the numbers of mitochondria in heart muscle. Mitochondria are the small components of muscle and other cells that convert fuel and oxygen to the easily usable forms of energy (ATP) that power all cell's activities. Adequate numbers of healthy mitochondria are essential to heart cell function. From animal and other studies we have reason to believe that breathing small amounts of CO will signal the body to increase the numbers of mitochondria in heart cells. We propose to test this theory in heart valve surgery patients by examining a small sample of heart tissue (from the right atrial appendage) that is routinely cut out during the preparation of the patient for cardio-pulmonary bypass and that would otherwise be discarded by the surgeon. Muscle samples from two groups of subjects will be compared. One group will breath CO and the other group will breath room air. If CO is effective, we should notice an increase in the numbers of mitochondria in the group that was exposed to CO compared to the group that breathed room air.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 12, 2012
Actual (reported)November 15, 2012
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)March 2016
Actual (reported)May 19, 2016
Actual (reported)Biochemical Markers for Mitochondrial Biogenesis (Blood and Right Atrial Tissue)
Right atrial biochemical markers will be measured one time only, intra-operatively. Blood Biochemical markers will be measured before CO exposure and at intervals up to one week post-operatively
2 weeks
Compare Blood to Right Atrial Tissue Biochemical Markers of Mitochondrial Biogenesis
on week
This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.
This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery.
This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
Duke Hospital
Durham, North Carolina, 27710, United States
Terminated study due to low accrual.
1 participants (actual enrollment reported by the registry).
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
May 19, 2016
Results First Posted
May 19, 2016
Record last verified: 2016-05
Only one subject was recruited. Funding was not obtained. The study was cancelled with the Duke IRB 3/16.
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Source: ClinicalTrials.gov.
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