Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride

  • STATUS
    Recruiting
  • End date
    Feb 1, 2025
  • participants needed
    8
  • sponsor
    Thomas Gleason, MD
Updated on 28 January 2021
open surgery
human chorionic gonadotropin
aortic valve insufficiency
pimonidazole hydrochloride

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 aortic aneurysm.

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 United States each year, and represent a serious clinical problem because there is a known, but unspecified risk of aortic rupture or dissection. Despite progress made in the surgical management of ascending aortic aneurysms, the molecular and cellular mechanisms involved remain elusive. However, indirect evidence of tissue hypoxia have recently been described in the literature.

This pilot study will use pimonidazole-HCl, a compound that is retained by hypoxic cells and that has been used for detection of tissue hypoxia in human since the early 2000s. This pilot study will involve twenty patients who are candidates for aortic replacement due to aneurysm and twenty non-aneurysmal patients undergoing coronary artery bypass graft (controls). Patients will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time. During surgery, the resected aneurysmal aortic specimens (for patients undergoing aortic replacement) or aortic punch (for patients undergoing coronary artery bypass graft) will be harvested. Tissue hypoxia will be qualitatively and quantitatively assessed in the investigator's research laboratory. Based on previous toxicological animal studies and previous use in human studies, the anticipated risk of severe or serious side effect will be relatively minimal.

Details
Condition Thoracic aortic aneurysm
Treatment Pimonidazole hydrochloride
Clinical Study IdentifierNCT03410420
SponsorThomas Gleason, MD
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Thoracic aortic aneurysm?
Do you have any of these conditions: Do you have Thoracic aortic aneurysm??
Do you have any of these conditions: Do you have Thoracic aortic aneurysm??
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
Platelets > 100,000/L
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 Criteria

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)
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