Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

NCT ID: NCT03622060

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-05-22

Brief Summary

A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of >95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.

Detailed Description

Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described.

The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.

Radial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.

Conditions

Radial Artery Injury at Wrist and Hand Level; Occlusion of Artery; Vasodilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Nitroglycerin

500 microgram intraarterial Nitroglycerin

Group Type: ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type: DRUG

200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal

Nicardipine

200 microgram intraraterial Nicardipine

Group Type: PLACEBO_COMPARATOR

Nitroglycerin

Intervention Type: DRUG

200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal

Interventions

Nitroglycerin

200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal

Intervention Type: DRUG

Other Intervention Names

Nicardipine

Eligibility Criteria

Inclusion Criteria

• All patients undergoing transradial catheterization

Exclusion Criteria

• Systolic blood pressure < 100 mmHg

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hermina Hospital Group

UNKNOWN

Sponsor Role: collaborator

Hermina Heart Center Kemayoran

OTHER

Sponsor Role: lead

Responsible Party

Surya Dharma, MD, PhD

NONERAO study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surya Dharma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hermina Hospital Kemayoran

Locations

Hermina Heart Center

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

References

Dharma S, Kedev S, Patel T, Kiemeneij F, Gilchrist IC. A novel approach to reduce radial artery occlusion after transradial catheterization: postprocedural/prehemostasis intra-arterial nitroglycerin. Catheter Cardiovasc Interv. 2015 Apr;85(5):818-25. doi: 10.1002/ccd.25661. Epub 2014 Sep 13.

Reference Type: RESULT

PMID: 25179153 (View on PubMed)

Other Identifiers

HerminaHCK

Identifier Type: -

Identifier Source: org_study_id