Nitroglycerin as Spasmolytic Regimen for RAS Prevention i... | NCT03889470

Studies
Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

NCT03889470

Sponsor

Hermina Heart Center Kemayoran

Status

Unknown status

Last Update Posted

Jun 4, 2019Actual

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

Radial Artery Injury

Interventions

NTG 1 MG/ML Injectable Solution

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2018Actual

Primary Completion Date

Sep 30, 2019Estimated

Completion Date

Oct 1, 2019Estimated

First Submitted Date

Mar 22, 2019

First Submission Date that Met QC Criteria

Mar 25, 2019

First Posted Date

Mar 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2019

Last Update Posted Date

Jun 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Surya Dharma, MD, PhD, MD, PhD, Hermina Heart Center KemayoranPrincipal Investigator

Lead Sponsor

Hermina Heart Center KemayoranOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NTG 1 MG/ML Injectable Solution	Drug	administered after sheath placement	200 microgram NTG Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of Moderate to severe radial artery spasm	arm pain associated with catheter manipulation (RAS grade 2 to 4)	During the index procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing transradial catheterisation using proximal radial artery puncture technique

Exclusion Criteria:

Blood pressure <100 mmHg
Refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agnes Intan, MD	Contact	622122608047	1234	agnesintan1231@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hermina Heart Center	Recruiting	Jakarta Pusat	DKI Jakarta	10630	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005996	Nitroglycerin

Ancestor Terms

ID	Term
D009574	Nitro Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided