Injury of Radial ArteryNORAONCT02105493
Nitroglycerin Prevents Radial Artery Occlusion
A study testing 500 microgram of Nitroglycerin and Saline 5 mL in people with Injury of Radial Artery, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Injury of Radial Artery
- What is being tested?
- 500 microgram of Nitroglycerin and Saline 5 mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,706 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with cardiogenic shock or hemodynamically unstable
- Unable to tolerate nitrates
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, Jakarta Special Capital Region, 11420
About this study
Official title: A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
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.
- Conditions
- Injury of Radial Artery
- Being tested
- 500 microgram of Nitroglycerin, Saline 5 mL
- Keywords
- Nitroglycerin, Radial Artery Occlusion, Transradial Catheterization
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 microgram of NitroglycerinDrug
Also called NTG
500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure
Saline 5 mLDrug
Also called NaCl 0,9% 5mL
Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure
| Study group | Role | What they receive |
|---|---|---|
| 500 microgram of Nitroglycerin | Active comparator | 500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure Receives: 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 Receives: Drug: Saline 5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Measured: One Day After the Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Radial ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,706 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surya Dharma, MD, PhD, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Surya Dharma, MD, PhD, Principal investigator, National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105493
- Sponsor's protocol ID
- NORAO2014
- Acronym
- NORAO
- Status last verified
- Mar 2014
- First submitted
- 19 Feb 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26797427
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
- ClinicalTrials.gov ID
- NCT02105493
- Acronym / sponsor ID
- NORAO / NORAO2014
- Conditions
- Injury of Radial Artery
- Keywords
- Nitroglycerin, Radial Artery Occlusion, Transradial Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 microgram of Nitroglycerin | Active comparator | Drug: 500 microgram of Nitroglycerin500 mcg nitroglycerin was given intra-arterially through the sheath at the end of a transradial procedure |
| Saline 5 mL | Placebo comparator | Drug: Saline 5 mL0,9% Saline 5 mL was given intra-arterially through the sheath at the end of a transradial procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with cardiogenic shock or hemodynamically unstable
- Unable to tolerate nitrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500 microgram of NitroglycerinAlso: NTG500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure | Drug | 500 microgram of Nitroglycerin |
| Saline 5 mLAlso: NaCl 0,9% 5mLSaline 5 mL given intra-arterially through the sheath at the end of transradial procedure | Drug | Saline 5 mL |
Primary outcome
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
Time frame: One Day After the Index Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Derived from this study: PubMed 26797427Dharma 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.
Related trials for Injury of Radial Artery
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Not yet recruiting
Blood'up Device Versus Manual Palpation for Arterial Puncture in Healthy Volunteers: A Pilot Randomized Study Under Normal and Simulated Hypotension
Arterial Puncture, Radial Artery Injury
Recruiting
Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
Iliotibial Band Syndrome
Recruiting
Treatment of Lateral Epicondylalgia With Shock Waves
Epicondylitis of the Elbow, Epicondylitis, Lateral
Active, not recruiting
RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability
Elbow Arthropathy, Elbow Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya Dharma, MD, PhD principal investigator
National Cardiovascular Center Harapan Kita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 microgram of Nitroglycerin and Saline 5 mL in people with Injury of Radial Artery, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound (time frame: One Day After the Index Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.