Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole-HCL
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|ClinicalTrials.gov Identifier: NCT03410420|
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm, Thoracic||Drug: pimonidazole-HCI||Phase 1|
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 :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective study designed to determine the safety and value of pimonidazole-HCl 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-HCL|
|Anticipated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2025|
Active Comparator: Non aneurysmal
Intervention: Twenty 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.
administration of pimonidazole-HCl
Intervention: Twenty 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.
administration of pimonidazole-HCl
- 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
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
|Contact: Thomas G Gleason, MDfirstname.lastname@example.org|
|Contact: Marie Billaudemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Thomas G Gleason, MD 412-802-8529 firstname.lastname@example.org|
|Contact: Melissa S Enlow, RN, MSN 412-647-1582 email@example.com|
|Principal Investigator:||Thomas G Gleason, MD||University of Pittsburgh|