Trial Outcomes & Findings for CO as a Stimulant for Mitochondrial Biogenesis in Human Cardiac Muscle (NCT NCT01727167)

NCT ID: NCT01727167

Last Updated: 2016-05-19

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-05-19

Participant Flow

Participant milestones

Participant milestones
Measure
Control Group
This group will breath room air for one hour per day over the course of the three days immediately prior to surgery. Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
CO Group
This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery. 200ppm CO for one hour: 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.
Overall Study
STARTED
1
0
Overall Study
COMPLETED
1
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CO as a Stimulant for Mitochondrial Biogenesis in Human Cardiac Muscle

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 weeks

Population: Molecular data was not collected for the single enrolled participant.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on week

Population: Molecular data was not collected for the single enrolled participant.

Biochemical markers in both right atrial tissue and blood will be measured and compared to see if the more easily obtained blood markers accurately describe changes expected in the heart.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

CO Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John J. Freiberger, M.D.

Duke University Medical Center

Phone: 919-684-6726

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place