NCT02343276

Brief Summary

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group). Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

January 15, 2015

Results QC Date

September 28, 2018

Last Update Submit

February 14, 2019

Conditions

Cardiac Catheterisation

Keywords

Radial Spasm

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment Using Visual Analogue Scale

    the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.

    Five minutes after sheath removal

Secondary Outcomes (2)

  • Procedure Duration

    Immediate

  • Radiation Exposure

    Immediate

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (saline solution 10 ml) in radial artery after sheath insertion

Other: Placebo

Intervention

EXPERIMENTAL

Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Drug: Nitroglycerin

Interventions

NitroglycerinDRUG

Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Also known as: Tridil
Intervention
PlaceboOTHER

Placebo (saline solution 10 ml) in radial artery after sheath insertion

Also known as: Saline solution
Placebo

Eligibility Criteria

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

You may qualify if:

  • Indication for cardiac catheterization
  • Suitable candidates for transradial approach

You may not qualify if:

  • AMI
  • Intubated patients
  • Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia de Santa Catarina

São Jose, Santa Catarina, 88000, Brazil

Location

MeSH Terms

Conditions

Spasm

Interventions

NitroglycerinSaline Solution

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Procedures were conducted in a single, high-volume center. All, but one, operators had high experience in radial access.

Results Point of Contact

Title
Roberto Léo da Silva
Organization
Instituto de Cardiologia de Santa Catarina
robertoleo@hotmail.com
55 48 32719077

Study Officials

  • Roberto L da Silva, MD

    Instituto de Cardiologia de Santa Catarina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 31, 2019

Results First Posted

May 31, 2019

Record last verified: 2019-02

Locations

BR(1)