Dye reveals hidden oxygen trouble in aortic aneurysms
NCT ID NCT03410420
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a dye called pimonidazole to see if it can safely detect low oxygen levels (hypoxia) in the aorta of people having surgery for an ascending aortic aneurysm. Nine adults received the dye before surgery, and researchers measured how much of it was in the removed aortic tissue. The goal was to learn more about the disease, not to treat it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Sep 2018
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Imaging CT scans and echography defining the presence of ascending aortic aneurysm will be centrally reviewed prospectively to ensure adherence to subject inclusion criteria. 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 serum glutamate oxaloacetate transaminase twice normal levels. 5. 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. 6. 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. 7. 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: 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 cardiovascular repair/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 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aortic aneurysm, thoracic are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a custom branched stent graft repair the aorta without open chest surgery?
- Eye ultrasound may spot brain swelling during aortic surgery
- Scientists probe hidden metabolic clues in aortic aneurysms
- Women may face higher risks after aortic aneurysm repair, study suggests
- Aortic aneurysm surgery under the microscope
- New stent grafts aim to fix aortic aneurysms without major surgery