Distal-Radial Approach using transdermal NitroGlycerin patch

JRCT ID: jRCTs051210128

Registered date:01/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Angina pectoris
• Date of first enrollment: 03/03/2022
• Target sample size: 92
• Study type: Interventional

Intervention(s)

Experimental drug group: Apply transdermal nitroglycerin patch (5 mg/disc) to upper arm on side of puncture 2-8 hours prior to catheterization.
Control group: No drug applied

Outcome(s)

• Primary Outcome: Success rate of distal radial artery puncture in the first puncture
• Secondary Outcome: Successful rate of distal radial artery puncture, number of punctures required for successful puncture, time required from start of puncture to sheath insertion, percentage of puncture requiring echographic guidance, diameter of distal radial artery and its change before and after drug application, percentage of arterial spasm occurrence, percentage of arterial occlusion on the day after the test, presence of hypotension before and during coronary angiography (systolic blood pressure less than 90 mmHg)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1. Patients aged 20 to 85 years at the time of consent
2. Patients with angina pectoris
3. Patients scheduled for coronary angipography (CAG) using the distal radial artery approach
4. Hospitalized the day before CAG
5. Patients scheduled for CAG using a Glidesheath Slender with an internal diameter of 5 French size.
6. Patients with written consent from the patient

Exclude criteria

1. Patients taking or applying nitric acid, nitrate ester, calcium channel blockers, and nicorandil.
2. Patients who are scheduled for provocation study of vasospastic angina.
3. Patients with previous catheterization or treatment from the ipsilateral distal radial artery.
4. Patients with unstable angina or acute coronary syndrome.
5. Patients with hypersensitivity to nitric acid and nitrite ester drugs.
6. Patients with hypotension at the time of obtaining consent (systolic blood pressure less than 90 mmHg).
7. Patients with severe anemia (hemoglobin less than 9.0g/dL) at the time of obtaining consent.
8. Patients with glaucoma, cerebral hemorrhage or head injury within 1 month.
9. Pregnant women, lactating women.
10. Patients taking phosphodiesterase 5 inhibiter or guanylate cyclase stimulator.
11. Patients who have already participated in other clinical trials or plan to participate in other clinical trials during this study.
12. Patients who have been judged inappropriate for participation in the study by the investigator or sub-investigator for any other reason.

Related Information

• Primary Sponsor: Murai Kota
• Source(s) of Monetary Support: Private donation to the Division of Coronary Diseases, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center.,Naohiko Miyata-Asahi Intecc Foundation for Medical Technology and Research,Academic support from CVIT