Arterial SpasmTRIESTENCT04317846
Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.
A study testing Intravenous administration of vasodilatory drugs in people with Arterial Spasm and Coronary Artery Disease, run by University of Lausanne Hospitals at 2 sites in Switzerland.
Trial summary
Radial artery access use in percutaneous cardiac interventions (PCI) is associated with a lower risk of vascular complications, bleeding and major adverse cardiac events including cardiac death in the long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Spasm, Coronary Artery Disease
- What is being tested?
- Intravenous administration of vasodilatory drugs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 22 Mar 2021to 30 Jun 2024
- 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
- Clinical indication for a coronary angiogram by radial route
- Age ≥18 years old
- Chronic coronary disease or stable acute coronary syndrome (NSTEMI, Non-ST Elevation Myocardial Infarction)
Who cannot join
- ST-Elevation Myocardial infarction
- Severe aortic stenosis (aortic valve area <0.8 cm2 or mean gradient > 40 mmHg)
- Severe left ventricular dysfunction (left ventricular ejection fraction < 30%).
- Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure < 90 mm Hg or heart rate < 45 bpm).
- Atrioventricular disturbances (atrioventricular block 2° or 3°).
- Contraindications to the class of drugs used in the trial, e.g. known hypersensitivity or allergy to class of drugs or the investigational
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- Women who are pregnant or breast feeding, Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Psychological disorders, dementia, etc. of the participant.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Rubimbura Vladimir
Lausanne, Canton of Vaud, 1011
Morges Hospital
Morges, Canton of Vaud, 1110
About this study
Official title: TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study
Radial artery access use in percutaneous cardiac interventions (PCI) is associated with a lower risk of vascular complications, bleeding and major adverse cardiac events including cardiac death in the long-term follow-up. Intra-radial administration of vasodilatory drugs, transiently painful for the patient, reduces the risk of spasm and is currently the standard technique performed worldwide. However, the efficacy of intravenous administration of vasodilatory drugs has never been evaluated.
Read the detailed description
Multicenter, randomised controlled trial, designed to evaluate the noninferiority of the intravenous administration of vasodilatory drugs in comparison with the actual gold standard intra-arterial radial route, in terms of radial artery diameter increase.
All consecutive patients with stable ischemic disease or stable acute coronary syndrome (NSTEMI - Non-ST elevation myocardial infarction) for whom a coronary procedure is planned will be included in the study. Three groups will be constituted. For all groups, the diameters of both radial arteries will be measured thrice by echo-Doppler: 5 minutes before sheath insertion, immediately before sheath insertion and 5 minutes after sheath insertion. Pain evaluation will be performed after injection of the vasodilatory drugs/placebo in the radial artery:
- Group 1 (control group): intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
- Group 2 (intravenous-post): intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
- Group 3 (intravenous-pre): intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
- Conditions
- Arterial Spasm, Coronary Artery Disease
- Being tested
- Intravenous administration of vasodilatory drugs
- Keywords
- radial spasm, percutaneous coronary intervention, vasodilatory drugs
- Medical subject headings
- Coronary Artery Disease, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of vasodilatory drugsOther
Administration of the vasodilatory drugs in a different pattern than intra-arterially
| Study group | Role | What they receive |
|---|---|---|
| Intra-radial group | Active comparator | intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) Receives: Other: Intravenous administration of vasodilatory drugs |
| Intravenous-post group | Experimental | intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) Receives: Other: Intravenous administration of vasodilatory drugs |
| Intravenous-pre group | Experimental | intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) Receives: Other: Intravenous administration of vasodilatory drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.
Radial artery diameter
Measured: 5 minutes after vasodilatory drugs administration
Secondary outcomes (3)
Pain evaluation after vasodilatory drugs administration using the intravenous versus intra-radial route
Scale from 0 to 10, lower values corresponding to lower pain and higher values to intense pain.
Measured: Procedure (During vasodilatory drugs administration)
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route
Measure of arterial pressure
Measured: 5 minutes after vasodilatory drugs administration
Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route
Measure of heart rate.
Measured: 5 minutes after vasodilatory drugs administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start22 Mar 2021
- Primary completion13 Feb 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial SpasmStudies 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
- Model description
- Multi-center randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche clinique - FBM-CHUV
- Responsible party
- Principal investigator, Vladimir Rubimbura, University of Lausanne Hospitals
- Investigators
- Vladimir Rubimbura, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317846
- Sponsor's protocol ID
- Trieste-study
- Acronym
- TRIESTE
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2020
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study
- ClinicalTrials.gov ID
- NCT04317846
- Acronym / sponsor ID
- TRIESTE / Trieste-study
- Conditions
- Arterial Spasm, Coronary Artery Disease
- Keywords
- radial spasm, percutaneous coronary intervention, vasodilatory drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Centre de recherche clinique - FBM-CHUV
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Mar 2020 (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.
Radial artery access use in percutaneous cardiac interventions (PCI) is associated with a lower risk of vascular complications, bleeding and major adverse cardiac events including cardiac death in the long-term follow-up. Intra-radial administration of vasodilatory drugs, transiently painful for the patient, reduces the risk of spasm and is currently the standard technique performed worldwide. However, the efficacy of intravenous administration of vasodilatory drugs has never been evaluated.
Detailed description
Multicenter, randomised controlled trial, designed to evaluate the noninferiority of the intravenous administration of vasodilatory drugs in comparison with the actual gold standard intra-arterial radial route, in terms of radial artery diameter increase.
All consecutive patients with stable ischemic disease or stable acute coronary syndrome (NSTEMI - Non-ST elevation myocardial infarction) for whom a coronary procedure is planned will be included in the study. Three groups will be constituted. For all groups, the diameters of both radial arteries will be measured thrice by echo-Doppler: 5 minutes before sheath insertion, immediately before sheath insertion and 5 minutes after sheath insertion. Pain evaluation will be performed after injection of the vasodilatory drugs/placebo in the radial artery:
- Group 1 (control group): intra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
- Group 2 (intravenous-post): intra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
- Group 3 (intravenous-pre): intra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Multi-center randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intra-radial group | Active comparator | Other: Intravenous administration of vasodilatory drugsintra-radial administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) |
| Intravenous-post group | Experimental | Other: Intravenous administration of vasodilatory drugsintra-venous administration of the vasodilatory drugs after sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) |
| Intravenous-pre group | Experimental | Other: Intravenous administration of vasodilatory drugsintra-venous administration of the vasodilatory drugs 5 minutes before sheath insertion (verapamil 2.5 mg + isosorbide dinitrate 0.5 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indication for a coronary angiogram by radial route
- Age ≥18 years old
- Chronic coronary disease or stable acute coronary syndrome (NSTEMI, Non-ST Elevation Myocardial Infarction)
Key exclusion criteria (9 listed)
- ST-Elevation Myocardial infarction
- Severe aortic stenosis (aortic valve area <0.8 cm2 or mean gradient > 40 mmHg)
- Severe left ventricular dysfunction (left ventricular ejection fraction < 30%).
- Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure < 90 mm Hg or heart rate < 45 bpm).
- Atrioventricular disturbances (atrioventricular block 2° or 3°).
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 |
|---|---|---|
| Intravenous administration of vasodilatory drugsAdministration of the vasodilatory drugs in a different pattern than intra-arterially | Other | Intra-radial group, Intravenous-post group, Intravenous-pre group |
Primary outcome
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route.
Time frame: 5 minutes after vasodilatory drugs administration
Radial artery diameter
3 secondary outcomes
Pain evaluation after vasodilatory drugs administration using the intravenous versus intra-radial route
Time frame: Procedure (During vasodilatory drugs administration)
Hemodynamic changes after vasodilatory drugs administration using the intravenous versus intra-radial route
Time frame: 5 minutes after vasodilatory drugs administration
Heart rate change after vasodilatory drugs administration using the intravenous versus intra-radial route
Time frame: 5 minutes after vasodilatory drugs administration
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 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Arterial Spasm
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The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography
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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.
Vladimir Rubimbura, MD principal investigator
MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous administration of vasodilatory drugs in people with Arterial Spasm and Coronary Artery Disease, run by University of Lausanne Hospitals at 2 sites in Switzerland.
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 9 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Maximal radial artery diameter dilation, measured by echo-doppler, after administration of vasodilatory drugs by intravenous or intra-radial route. (time frame: 5 minutes after vasodilatory drugs administration). 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 6 Aug 2024.