Cardiac CatheterisationPhase 3NCT02343276

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

A Phase 3 study testing Nitroglycerin in people with Cardiac Catheterisation, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Catheterisation
What is being tested?: Nitroglycerin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 328 participants
Where: 1 siteBrazil
Study dates: Feb 2015to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Indication for cardiac catheterization
Suitable candidates for transradial approach

Who cannot join

AMI
Intubated patients
Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
Prior inclusion in this trial

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Instituto de Cardiologia de Santa Catarina
São Jose, Santa Catarina, 88000

Other trials in Brazil

About this study

Official title: Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Conditions: Cardiac Catheterisation
Being tested: Nitroglycerin, Placebo
Keywords: Radial Spasm
Medical subject headings: Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NitroglycerinDrug
Also called Tridil
Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
PlaceboOther
Also called Saline solution
Placebo (saline solution 10 ml) in radial artery after sheath insertion

Study groups in NCT02343276
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo (saline solution 10 ml) in radial artery after sheath insertion Receives: Other: Placebo
Intervention	Experimental	Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion Receives: Drug: Nitroglycerin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Assessment Using Visual Analogue Scale
the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.
Measured: Five minutes after sheath removal

Secondary outcomes (2)

Procedure Duration
Procedure duration, from artery catheterization up to removal of sheath.
Measured: Immediate
Radiation Exposure
Total radiation required to complete the procedure.
Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Aug 2015

First posted21 Jan 2015 (estimated)
Study startFeb 2015
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac CatheterisationStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02343276
Sponsor's protocol ID: ICSC-2015
Status last verified: Feb 2019
First submitted: 15 Jan 2015
Last updated: 31 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.
ClinicalTrials.gov ID: NCT02343276
Acronym / sponsor ID: ICSC-2015
Conditions: Cardiac Catheterisation
Keywords: Radial Spasm
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 328 participants (actual)
Lead sponsor: Instituto de Cardiologia de Santa CatarinaUniversity, hospital or other
Study start: Feb 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 21 Jan 2015 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboPlacebo (saline solution 10 ml) in radial artery after sheath insertion
Intervention	Experimental	Drug: NitroglycerinNitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Indication for cardiac catheterization
Suitable candidates for transradial approach

Key exclusion criteria (4 listed)

AMI
Intubated patients
Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
Prior inclusion in this trial

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
NitroglycerinAlso: TridilNitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion	Drug	Intervention
PlaceboAlso: Saline solutionPlacebo (saline solution 10 ml) in radial artery after sheath insertion	Other	Placebo

Primary outcome

Pain Assessment Using Visual Analogue Scale
Time frame: Five minutes after sheath removal
the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.

2 secondary outcomes

Procedure Duration
Time frame: Immediate
Radiation Exposure
Time frame: Immediate

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	164	164
Intervention	164	164

Primary outcome: Pain Assessment Using Visual Analogue Scale

Time frame: Five minutes after sheath removal. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 164	Intervention n = 164
Value	24.75 (23.1)	24.74 (26.0)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 164 (0%)	0 of 164 (0%)	Not reported
Intervention	0 of 164 (0%)	0 of 164 (0%)	Not reported

Limitations and caveats (from the sponsor): Procedures were conducted in a single, high-volume center. All, but one, operators had high experience in radial access.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingObservational study
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RecruitingObservational study
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Not yet recruiting
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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.

Roberto L da Silva, MD principal investigator

Instituto de Cardiologia de Santa Catarina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nitroglycerin in people with Cardiac Catheterisation, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.

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 2 inclusion and 4 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 31 May 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Assessment Using Visual Analogue Scale (time frame: Five minutes after sheath removal). 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 NCT02343276.

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 31 May 2019.