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Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion (NONERAO)

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ClinicalTrials.gov Identifier: NCT03622060
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Hermina Hospital Group
Information provided by (Responsible Party):
Surya Dharma, MD, PhD, Hermina Heart Center Kemayoran

Brief Summary:
A total of 200 patients undergoing coronary procedures via transradial access with a 6-F sheath will be 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% and measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early and late RAO which will be evaluated by color duplex ultrasonography of the accessed arteries at 24 h - 48 h and 30 days after the procedure. Secondary outcome will be the change of blood pressure before and 2-3 minutes after drug administration. Logistic regression was used to find the association between use of vasodilators and RAO.

Condition or disease Intervention/treatment Phase
Radial Artery Injury at Wrist and Hand Level Occlusion of Artery Vasodilation Drug: Nitroglycerin Phase 3

Detailed Description:

Doppler ultrasound of the accessed artery will be performed within 48 h and 30 days 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 will also be evaluated as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: nitroglycerin and nicardipine
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitroglycerin
500 microgram intraarterial Nitroglycerin
Drug: Nitroglycerin
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
Other Name: Nicardipine

Placebo Comparator: Nicardipine
200 microgram intraraterial Nicardipine
Drug: Nitroglycerin
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
Other Name: Nicardipine




Primary Outcome Measures :
  1. The absence of antegrade radial artery flow by doppler evaluation [ Time Frame: 24 hour ]
    The absence of radial artery flow by doppler evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing transradial catheterization

Exclusion Criteria:

  • Systolic blood pressure < 90 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622060


Contacts
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Contact: Surya Dharma, MD, PhD +622122608771 ext 9 drsuryadharma@yahoo.com
Contact: Agnes Intan, MD +622122608771 ext 9 agnesintan@yahoo.com

Locations
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Indonesia
Hermina Heart Center Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10630
Contact: Surya Dharma, MD, PhD    +622122608771 ext 9    drsuryadharma@yahoo.com   
Sponsors and Collaborators
Hermina Heart Center Kemayoran
Hermina Hospital Group
Investigators
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Principal Investigator: Surya Dharma, MD, PhD Hermina Hospital Kemayoran

Publications of Results:
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Responsible Party: Surya Dharma, MD, PhD, NONERAO study, Hermina Heart Center Kemayoran
ClinicalTrials.gov Identifier: NCT03622060     History of Changes
Other Study ID Numbers: HerminaHCK
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nitroglycerin
Nicardipine
Vasodilator Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs