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OpenTrials
Completed

NCT Number: NCT03622060

Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

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.

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Key information

Conditions

Radial Artery Injury at Wrist and Hand Level Aneurysm Arterial Occlusive Diseases Cardiovascular Diseases Occlusion of Artery Vascular Diseases Vasodilation

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hermina Heart Center

Jakarta Pusat, DKI Jakarta, 10630, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing transradial catheterization

Exclusion criteria

  • Systolic blood pressure < 100 mmHg

Treatment and study plan

Nitroglycerin

Drug

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

Other names: Nicardipine

Primary outcomes

  1. The absence of antegrade radial artery flow by doppler evaluation

    Time frame: 24 hour

    The absence of radial artery flow by doppler evaluation

  2. Blood pressure change

    Time frame: 2 minutes after drugs administration

    Blood pressure change after drugs administration

Sponsors and collaborators

Lead sponsor

Hermina Heart Center Kemayoran

Other

Collaborators

  • Hermina Hospital Group

Registry information

Official study title

A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization

Acronym: NONERAO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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