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Trial record 17 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride

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ClinicalTrials.gov Identifier: NCT03410420
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Gleason, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Drug: Pimonidazole hydrochloride Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Non aneurysmal
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
administration of pimonidazole-HCl

Experimental: Aneurysmal
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
administration of pimonidazole-HCl




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410420


Contacts
Contact: Thomas G Gleason, MD 412-802-8529 gleasontg@upmc.edu
Contact: Marie Billaud 412-624-5395 billaudm@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Thomas G Gleason, MD    412-802-8529    gleasontg@upmc.edu   
Contact: Melissa S Enlow, RN, MSN    412-647-1582    enlowms@upmc.edu   
Sponsors and Collaborators
Thomas Gleason
Investigators
Principal Investigator: Thomas G Gleason, MD University of Pittsburgh

Responsible Party: Thomas Gleason, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03410420     History of Changes
Other Study ID Numbers: PRO16050046
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Gleason, University of Pittsburgh:
Thoracic Aortic Aneurysm
Hypoxia
Ascending Aorta
Hypoxyprobe
Pimonidazole

Additional relevant MeSH terms:
Aneurysm
Hypoxia
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Aortic Diseases