Intravenous Cerebral Angiography in Balloon Test Occlusion

JRCT ID: jRCT1032240337

Registered date:17/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled for carotid artery occlusion testing
• Date of first enrollment: 21/10/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Balloon test occlusion by cerebral angiography using intravenous injection

Outcome(s)

Primary Outcome

To evaluate the delay (in seconds) of cortical vein visualization during cerebral angiography using intraarterial and venous injection and assess its correlation coefficient
Two contrast-enhanced images obtained from the same subject will be individually evaluated by three specialists: two neurologists or neurosurgeons from the institution where the imaging was conducted and one neurologist or neurosurgeon from another facility. They will each assess the images and determine the delay in seconds.

Secondary Outcome

A. To score the quality of images between intraarterial and intravenous injections.
Select one of the four categories for the ability to detect cerebral cortical veins:
1. There is no difference in the quality of venous-phase images, and evaluation of cortical veins is possible.
2. The quality of venous-phase images differs, but this does not hinder the evaluation of cortical veins.
3. The quality of venous-phase images differs, hindering the evaluation of cortical veins, but evaluation is still possible.
4. There is a difference in the quality of venous-phase images, and evaluating cortical veins is impossible.
B. Consider factors influencing the correlation coefficient of the primary outcome.
C. Comparison of fluoroscopy time (seconds), radiation exposure (mGy), and contrast agent volume (cc) during the test.
D. To score the sensation of heat or discomfort felt during the transarterial and transvenous injection.
Score from 1 to 10, where 1 is the weakest and ten is the strongest.
E. Presence of complications at the puncture site.
F. Presence of brain infarction in cases where the internal carotid artery on the trial side was occluded, NIHSS and mRS three months after occlusion

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 18 years old or older
2. Patients scheduled for carotid artery occlusion testing
3. Patients who have received sufficient explanation of the trial and have provided written consent based on their full understanding and free will

Exclude criteria

1. Patients who cannot use heparin
2. Patients with renal dysfunction (eGFR < 60)
3. Patients with reduced left ventricular ejection fraction (< 40%)
4. Patients with symptomatic heart failure requiring hospitalization and treatment
5. Pregnant women or women who may be pregnant
6. Breastfeeding women
7. Patients with a history of iodine allergy
8. Other patients deemed inappropriate by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Matsumaru Yuji
• Source(s) of Monetary Support: University of Tsukuba Hospital