Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride

NCT03410420 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19090250
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 aortic aneurysm.

Conditions

Aortic Aneurysm, Thoracic

Keywords

Thoracic Aortic Aneurysm; Hypoxia; Ascending Aorta; Hypoxyprobe; Pimonidazole

Outcome Measures

Primary Outcomes (1)

• 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

  < 1 week

Study Arms (2)

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.

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.

Drug: Pimonidazole hydrochloride

Interventions

Pimonidazole hydrochloride DRUG

administration of pimonidazole-HCl

Aneurysmal; Non aneurysmal

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Thomas Gleason: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Hypoxia

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas G Gleason, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 25, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)