CoronaropathyNCT02258620
Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.
A study testing dinitrate isosorbide and nitroglycerine in people with Coronaropathy, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in intra-arterial have been widely studied in prevention of this spasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronaropathy
- What is being tested?
- dinitrate isosorbide and nitroglycerine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 ans.
- Patients with hemodynamic stability.
- Patients informed consent was signed by each individual. The study obtained approval from the local ethics committee.
Who cannot join
- 'Test d'Allen' negative
- Pregnancy.
- STEMI
- Hemodynamic Instability : PAS < 100 mmHg, FC > 100 bpm, tachycardia uncontrollable.
- Allergy of nitrates.
Trial locations and contacts
1 site in 1 country.
About this study
The radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in intra-arterial have been widely studied in prevention of this spasm. No studies have compared the different routes of administration of nitrates as a patch and a continuous intravenous injection.
Read the detailed description
The radial approach is favored for coronary angiography due of several advantages: reduction of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and time reduction of hospitalization, improved patient ulterior comfort. However, this approach is subject to an immediate major complication that is the radial artery spasm (RAS) which, according to the criteria used, has an average incidence of 30%. The administration of a vasodilator just before coronary angiography procedure enables an increase of the radial artery diameter and thus a decrease of friction probes. Theoretically this prevents the occurrence of the RAS.
The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)). Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it was a direct injection and without proof of its superiority over IA. The para-radial subcutaneous injection has only been studied to facilitate access to the radial artery. The investigators randomized study compares, for the first time, the effectiveness of the transdermal administration of trinitrine (D) and continuous intravenous of dinitrate isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.
- Conditions
- Coronaropathy
- Being tested
- dinitrate isosorbide, nitroglycerine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinitrate isosorbideDrug
dinitrate isosorbide (cedocard*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard*) 5 mg by intra arterial direct in the sheat
nitroglycerineDrug
nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2
| Study group | Role | What they receive |
|---|---|---|
| dinitrate isosorbide (intra venous) | Experimental | dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h) Receives: Drug: dinitrate isosorbide |
| dinitrate isosorbide (intra arterial) | Experimental | dinitrate isosorbide 5 mg by direct administration intra arterial Receives: Drug: dinitrate isosorbide |
| nitroglycerine (transdermic) | Experimental | nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2 Receives: Drug: nitroglycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery diameter
With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure)
Measured: Day of administration
Probe friction
Probe friction, as experienced by the operator (subjective measure)
Measured: Day of administration
Pain
Pain felt by the patient in the forearm (subjective measure)
Measured: Day of administration
Radial artery occlusion
Evaluation of the radial artery occlusion 3 months post procedure
Measured: 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronaropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Castro, Brugmann University Hospital
- Investigators
- José Castro, MD, Principal investigator, CHU-Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258620
- Sponsor's protocol ID
- CHUB-SAR
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.
- ClinicalTrials.gov ID
- NCT02258620
- Acronym / sponsor ID
- CHUB-SAR
- Conditions
- Coronaropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Oct 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.
The radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in intra-arterial have been widely studied in prevention of this spasm. No studies have compared the different routes of administration of nitrates as a patch and a continuous intravenous injection.
Detailed description
The radial approach is favored for coronary angiography due of several advantages: reduction of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and time reduction of hospitalization, improved patient ulterior comfort. However, this approach is subject to an immediate major complication that is the radial artery spasm (RAS) which, according to the criteria used, has an average incidence of 30%. The administration of a vasodilator just before coronary angiography procedure enables an increase of the radial artery diameter and thus a decrease of friction probes. Theoretically this prevents the occurrence of the RAS.
The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)). Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it was a direct injection and without proof of its superiority over IA. The para-radial subcutaneous injection has only been studied to facilitate access to the radial artery. The investigators randomized study compares, for the first time, the effectiveness of the transdermal administration of trinitrine (D) and continuous intravenous of dinitrate isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dinitrate isosorbide (intra venous) | Experimental | Drug: dinitrate isosorbidedinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h) |
| dinitrate isosorbide (intra arterial) | Experimental | Drug: dinitrate isosorbidedinitrate isosorbide 5 mg by direct administration intra arterial |
| nitroglycerine (transdermic) | Experimental | Drug: nitroglycerinenitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 ans.
- Patients with hemodynamic stability.
- Patients informed consent was signed by each individual. The study obtained approval from the local ethics committee.
Key exclusion criteria (5 listed)
- 'Test d'Allen' negative
- Pregnancy.
- STEMI
- Hemodynamic Instability : PAS < 100 mmHg, FC > 100 bpm, tachycardia uncontrollable.
- Allergy of 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 |
|---|---|---|
| dinitrate isosorbidedinitrate isosorbide (cedocard*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard*) 5 mg by intra arterial direct in the sheat | Drug | dinitrate isosorbide (intra arterial), dinitrate isosorbide (intra venous) |
| nitroglycerinenitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2 | Drug | nitroglycerine (transdermic) |
Primary outcome
Radial artery diameter
Time frame: Day of administration
With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure)
Probe friction
Time frame: Day of administration
Probe friction, as experienced by the operator (subjective measure)
Pain
Time frame: Day of administration
Pain felt by the patient in the forearm (subjective measure)
Radial artery occlusion
Time frame: 3 months post procedure
Evaluation of the radial artery occlusion 3 months post 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 Oct 2014.
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.
José Castro, MD principal investigator
CHU-Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dinitrate isosorbide and nitroglycerine in people with Coronaropathy, run by Brugmann University Hospital at 1 site in Belgium.
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 3 inclusion and 5 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 Oct 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 Belgium. 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. 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?
Radial artery diameter (time frame: Day of administration). The study lists 4 primary outcomes in all. 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 7 Oct 2014.