NCT02105493

Brief Summary

Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,706

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

February 19, 2014

Last Update Submit

April 2, 2014

Conditions

Injury of Radial Artery

Keywords

NitroglycerinRadial Artery OcclusionTransradial Catheterization

Outcome Measures

Primary Outcomes (1)

  • Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound

    One Day After the Index Procedure

Study Arms (2)

500 microgram of Nitroglycerin

ACTIVE COMPARATOR

500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure

Drug: 500 microgram of Nitroglycerin

Saline 5 mL

PLACEBO COMPARATOR

0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure

Drug: Saline 5 mL

Interventions

500 microgram of NitroglycerinDRUG

500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure

Also known as: NTG
500 microgram of Nitroglycerin
Saline 5 mLDRUG

Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure

Also known as: NaCl 0,9% 5mL
Saline 5 mL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure.

You may not qualify if:

  • Patients with cardiogenic shock or hemodynamically unstable
  • Unable to tolerate nitrates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, Jakarta Special Capital Region, 11420, Indonesia

Location

Related Publications (1)

  • Dharma S, Kedev S, Patel T, Sukmawan R, Gilchrist IC, Rao SV. Post-procedural/pre-hemostasis intra-arterial nitroglycerin after transradial catheterization: A gender based analysis. Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):10-4. doi: 10.1016/j.carrev.2015.12.002. Epub 2015 Dec 22.

    PMID: 26797427DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Surya Dharma, MD, PhD

    National Cardiovascular Center Harapan Kita

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 19, 2014

First Posted

April 7, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 7, 2014

Record last verified: 2014-03

Locations

ID(1)