Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride

Inclusion Criteria:

1. Adults ≥ 18 years of age who require one of the following open surgery:

• Ascending thoracic aorta repair due to aneurysm;

• Aortic valve replacement due to aortic valve insufficiency;

• Coronary artery bypass graft procedure due to coronary heart disease. ImagingCT scans and echography defining the presence of ascending aortic aneurysm willbe centrally reviewed prospectively to ensure adherence to subject inclusioncriteria.

2. Adequate hematologic functions:

• White blood cells > 2500/µ;

• Platelets > 100,000/µL;

• Hemoglobin > 8 g/dl.

3. Adequate renal functions: serum creatinine < 2.0 mg/dl.

4. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and serumglutamate oxaloacetate transaminase twice normal levels.

5. If the subject or partner is of childbearing potential, he or she must be willing touse adequate contraception (hormonal or barrier method or abstinence) from the timeof screening and for a period of at least 16 weeks after procedure.

6. Capable of giving written informed consent, which includes compliance with therequirements and restrictions listed in the consent form, release of medicalinformation, and Health Insurance Portability and Accountability Act (HIPAA)documentation.

7. Female subjects of childbearing potential must have a negative serum pregnancy testat screening. human chorionic gonadotropin levels will be assessed for all women ofchildbearing years prior to the procedure.

Exclusion Criteria:

1. Severe septicemia or severe infection in the 4 weeks prior to study entry;

2. The subject has a baseline NIHSS > 1 or modified Rankin Scale > 1.

3. Active participation in other research therapy for cardiovascularrepair/regeneration;

4. Pregnant or breastfeeding at time of screening;

5. Cardiothoracic surgery within 30 days prior to screening;

6. The subject has participated in a clinical trial and has received an investigationalproduct within the following time period prior to the first dosing day in thecurrent study: 30 days, 5 half-lives or twice the duration of the biological effectof the investigational product (whichever is longer).