Aortic Aneurysm, ThoracicPhase 1NCT03410420
Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
A Phase 1 study testing Pimonidazole hydrochloride in people with Aortic Aneurysm, Thoracic, run by Thomas Gleason at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Pimonidazole hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
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.
Read the 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 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.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Pimonidazole hydrochloride
- Keywords
- Thoracic Aortic Aneurysm, Hypoxia, Ascending Aorta, Hypoxyprobe, Pimonidazole
- Medical subject headings
- Aortic Aneurysm, Thoracic, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimonidazole hydrochlorideDrug
administration of pimonidazole-HCl
| Study group | Role | What they receive |
|---|---|---|
| Non aneurysmal | Active comparator | Intervention: four non-aneurysmal patients undergoing coronary artery bypass graft or aortic valve replacement will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time. Receives: Drug: Pimonidazole hydrochloride |
| Aneurysmal | Experimental | Intervention: four patients who are candidates for aortic replacement due to aneurysm will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time. Receives: Drug: Pimonidazole hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of pimonidazole-HCl in aortic specimens
Levels of pimonidazole-HCl will be quantified in aortic specimens from patients who were administered pimonidazole-HCl prior to surgery
Measured: < 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective study designed to determine the safety and value of pimonidazole hydrochloride to detect levels of tissue hypoxia in patients presenting with ascending aortic aneurysm
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Gleason
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Gleason, University of Pittsburgh
- Investigators
- Thomas G Gleason, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410420
- Sponsor's protocol ID
- STUDY19090250
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2018
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
- ClinicalTrials.gov ID
- NCT03410420
- Acronym / sponsor ID
- STUDY19090250
- Conditions
- Aortic Aneurysm, Thoracic
- Keywords
- Thoracic Aortic Aneurysm, Hypoxia, Ascending Aorta, Hypoxyprobe, Pimonidazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thomas GleasonUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective study designed to determine the safety and value of pimonidazole hydrochloride to detect levels of tissue hypoxia in patients presenting with ascending aortic aneurysm
| Arm | Type | Receives |
|---|---|---|
| Non aneurysmal | Active comparator | Drug: Pimonidazole hydrochlorideIntervention: four non-aneurysmal patients undergoing coronary artery bypass graft or aortic valve replacement will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time. |
| Aneurysmal | Experimental | Drug: Pimonidazole hydrochlorideIntervention: four patients who are candidates for aortic replacement due to aneurysm will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults ≥ 18 years of age who require one of the following open surgery:
- Adequate hematologic functions:
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimonidazole hydrochlorideadministration of pimonidazole-HCl | Drug | Aneurysmal, Non aneurysmal |
Primary outcome
Detection of pimonidazole-HCl in aortic specimens
Time frame: < 1 week
Levels of pimonidazole-HCl will be quantified in aortic specimens from patients who were administered pimonidazole-HCl prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas G Gleason, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pimonidazole hydrochloride in people with Aortic Aneurysm, Thoracic, run by Thomas Gleason at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of pimonidazole-HCl in aortic specimens (time frame: < 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.