Status:
COMPLETED
Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
Lead Sponsor:
Thomas Gleason
Conditions:
Aortic Aneurysm, Thoracic
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
This is a prospective study designed to determine the safety and value of Hypoxyprobe-1 (pimonidazole hydrochloride (-HCl)) to detect levels of tissue hypoxia in patients presenting with ascending aor...
Detailed Description
The proposed study is designed to identify the level of tissue hypoxia in patients presenting with ascending aortic aneurysm. Ascending aortic aneurysms affect approximately 15,000 people in the Unite...
Eligibility Criteria
Inclusion
- 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. Imaging CT scans and echography defining the presence of ascending aortic aneurysm will be centrally reviewed prospectively to ensure adherence to subject inclusion criteria.
- Adequate hematologic functions:
- White blood cells \> 2500/µ;
- Platelets \> 100,000/µL;
- Hemoglobin \> 8 g/dl.
- Adequate renal functions: serum creatinine \< 2.0 mg/dl.
- Adequate hepatic function: serum alkaline phosphatase, bilirubin, and serum glutamate oxaloacetate transaminase twice normal levels.
- If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening. human chorionic gonadotropin levels will be assessed for all women of childbearing years prior to the procedure.
Exclusion
- Severe septicemia or severe infection in the 4 weeks prior to study entry;
- The subject has a baseline NIHSS \> 1 or modified Rankin Scale \> 1.
- Active participation in other research therapy for cardiovascular repair/regeneration;
- Pregnant or breastfeeding at time of screening;
- Cardiothoracic surgery within 30 days prior to screening;
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03410420
Start Date
October 1 2018
End Date
April 1 2022
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219