Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

NCT ID: NCT03889470

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2019-10-01

Brief Summary

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The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.

Detailed Description

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Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure.

Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.

Conditions

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Radial Artery Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

NTG vs Placebo
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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200 microgram NTG

200 microgram NTG through the radial sheath

Group Type ACTIVE_COMPARATOR

NTG 1 MG/ML Injectable Solution

Intervention Type DRUG

administered after sheath placement

Saline

Saline infusion through the radial sheath

Group Type PLACEBO_COMPARATOR

NTG 1 MG/ML Injectable Solution

Intervention Type DRUG

administered after sheath placement

Interventions

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NTG 1 MG/ML Injectable Solution

administered after sheath placement

Intervention Type DRUG

Other Intervention Names

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Nitroglycerin

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing transradial catheterisation using proximal radial artery puncture technique

Exclusion Criteria

* Blood pressure \<100 mmHg
* Refuse to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hermina Heart Center Kemayoran

OTHER

Sponsor Role lead

Responsible Party

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Surya Dharma, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hermina Heart Center

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Agnes Intan, MD

Role: CONTACT

622122608047 ext. 1234

Facility Contacts

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Surya Dharma, MD, PhD

Role: primary

+622122608771 ext. 9

Other Identifiers

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HerminaHCKRAS

Identifier Type: -

Identifier Source: org_study_id

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