Patients with spinal cord disease, aortic disease, etc. Adamkiewicz artery, spinal and spinal cord disease, Aortic disease
Conditions
Interventions
When patients with spinal/spinal cord disease, aortic disease, etc. undergo contrast CT for the identification test, one sublingual nitroglycerin (Nitropen sublingual tablet (0.3 mg)) is administered
nitroglycerin, CT angiography
Sponsors
Sumita Kazutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with spinal cord disease, aortic disease, or other conditions for whom contrast-enhanced CT is planned to identify the anatomical location of the Adamkiewicz artery when deciding on a treatment plan 2) Patients whose clinical laboratory values within 2 weeks prior to enrollment meet the following criteria 1. Hb >=10.0 g/dL 2. eGFR >=30 mL/min/1.73m2 3. Patients who are 20 years of age or older at the time of obtaining consent 4.Patients who have given written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to nitroglycerin 1 to 5 below 1. Patients with hypotension or cardiogenic shock with systolic blood pressure of 80 mmHg or less 2. Patients with closed-angle glaucoma 3. Patients with head injury or cerebral hemorrhage 4.Patients with a history of hypersensitivity to nitrates/nitrites 5.Patients receiving phosphodiesterase 5 inhibitors (sildenafil citrate, vardenafil hydrochloride hydrate, tadalafil) or guanylate cyclase stimulating agents (riociguat) 2) Patients with allergy to iodine contrast media 3) Patients with foreign bodies implanted in the body that produce artifacts that make CT evaluation difficult 4) Women who are pregnant or of childbearing potential 5) Women who are breast-feeding 6) Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adamkiewicz artery delineation rate (independent central determination) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adamkiewicz artery delineation rate (physician's judgment) 2)Agreement rate of segmental location of Adamkiewicz artery between spinal cord angiography and contrast-enhanced CT (judged by attending physician) Exploratory endpoints Contrast CT under sublingual nitroglycerin administration will be examined for vessel diameters and CT values at sites such as the apex of the intradural hairpin curve and the transdural point of the Adamkiewicz artery.An exploratory comparison of findings with spinal cord angiography will also be performed. Safety endpoints Percentage of adverse events Adverse events of particular interest: 1.Percentage of patients who developed hypotension with a systolic blood pressure of 80 mmHg or less, or who developed symptoms attributable to vasodilation or hypotension such as headache, nausea/vomiting, and dizziness within 30 minutes of completion of a contrast CT scan using nitroglycerin 2. Percentage of patients in whom 1.above was still present 30 minutes after the contrast CT scan was completed. | — |
Contacts
Public ContactSakyo Hirai
Institute of Science Tokyo Hospital
Outcome results
None listed