NCT03889470

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

March 22, 2019

Last Update Submit

June 1, 2019

Conditions

Radial Artery Injury

Keywords

transradial catheterisationradial artery spasm

Outcome Measures

Primary Outcomes (1)

  • The incidence of Moderate to severe radial artery spasm

    arm pain associated with catheter manipulation (RAS grade 2 to 4)

    During the index procedure

Study Arms (2)

200 microgram NTG

ACTIVE COMPARATOR

200 microgram NTG through the radial sheath

Drug: NTG 1 MG/ML Injectable Solution

Saline

PLACEBO COMPARATOR

Saline infusion through the radial sheath

Drug: NTG 1 MG/ML Injectable Solution

Interventions

NTG 1 MG/ML Injectable SolutionDRUG

administered after sheath placement

Also known as: Nitroglycerin
200 microgram NTGSaline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Blood pressure \<100 mmHg
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hermina Heart Center

Jakarta Pusat, DKI Jakarta, 10630, Indonesia

RECRUITING

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Central Study Contacts

Agnes Intan, MD

CONTACT

622122608047agnesintan1231@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: NTG vs Placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

March 31, 2018

Primary Completion

September 30, 2019

Study Completion

October 1, 2019

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)