Radial Artery InjuryPhase 4NORASNCT03889470
Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center
A Phase 4 study testing NTG 1 MG/ML Injectable Solution in people with Radial Artery Injury, run by Hermina Heart Center Kemayoran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radial Artery Injury
- What is being tested?
- NTG 1 MG/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Mar 2018to 1 Oct 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing transradial catheterisation using proximal radial artery puncture technique
Who cannot join
- Blood pressure <100 mmHg
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Hermina Heart Center
Jakarta Pusat, DKI Jakarta, 10630
Surya Dharma, MD, PhD, +622122608771 ext. 9, drsuryadharma@yahoo.com
About this study
Official title: A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center
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.
Read the 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.
- Conditions
- Radial Artery Injury
- Being tested
- NTG 1 MG/ML Injectable Solution
- Keywords
- transradial catheterisation, radial artery spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTG 1 MG/ML Injectable SolutionDrug
Also called Nitroglycerin
administered after sheath placement
| Study group | Role | What they receive |
|---|---|---|
| 200 microgram NTG | Active comparator | 200 microgram NTG through the radial sheath Receives: Drug: NTG 1 MG/ML Injectable Solution |
| Saline | Placebo comparator | Saline infusion through the radial sheath Receives: Drug: NTG 1 MG/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Moderate to severe radial artery spasm
arm pain associated with catheter manipulation (RAS grade 2 to 4)
Measured: During 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 posted26 Mar 2019
- Study start31 Mar 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery InjuryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- NTG vs Placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hermina Heart Center Kemayoran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surya Dharma, MD, PhD, Hermina Heart Center Kemayoran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889470
- Sponsor's protocol ID
- HerminaHCKRAS
- Acronym
- NORAS
- Status last verified
- Jun 2019
- First submitted
- 22 Mar 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center
- ClinicalTrials.gov ID
- NCT03889470
- Acronym / sponsor ID
- NORAS / HerminaHCKRAS
- Conditions
- Radial Artery Injury
- Keywords
- transradial catheterisation, radial artery spasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hermina Heart Center KemayoranUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 26 Mar 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- NTG vs Placebo
| Arm | Type | Receives |
|---|---|---|
| 200 microgram NTG | Active comparator | Drug: NTG 1 MG/ML Injectable Solution200 microgram NTG through the radial sheath |
| Saline | Placebo comparator | Drug: NTG 1 MG/ML Injectable SolutionSaline infusion through the radial sheath |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing transradial catheterisation using proximal radial artery puncture technique
Key exclusion criteria (2 listed)
- Blood pressure <100 mmHg
- Refuse to participate
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 |
|---|---|---|
| NTG 1 MG/ML Injectable SolutionAlso: Nitroglycerinadministered after sheath placement | Drug | 200 microgram NTG, Saline |
Primary outcome
The incidence of Moderate to severe radial artery spasm
Time frame: During the index procedure
arm pain associated with catheter manipulation (RAS grade 2 to 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NTG 1 MG/ML Injectable Solution in people with Radial Artery Injury, run by Hermina Heart Center Kemayoran 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes Intan, MD (622122608047 ext. 1234, agnesintan1231@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Moderate to severe radial artery spasm (time frame: During the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.