Exposure to Ionizing RadiationEXPERTNCT01794325
Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors
A study testing Trans-radial and Trans-femoral in people with Exposure to Ionizing Radiation and Coronary Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Exposure to Ionizing Radiation, Coronary Heart Disease, Vascular Access Complication
- What is being tested?
- Trans-radial and Trans-femoral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for a elective coronary angiography
- Eligible for either transfemoral or transradial approach
- Accept to sign the written consent form (WCF)
Who cannot join
- Refusal to sign the WCF
- End stage renal failure
- Urgency/Emergency procedure
- Contraindication to perform both coronary and left ventricle angiogram
- Necessity of another vascular angiogram during coronary angiography
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90520-000
About this study
Official title: Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.
The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.
- Being tested
- Trans-radial, Trans-femoral
- Keywords
- Occupational radiation exposure, Transradial approach, Transfemoral approach
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-radialOther
Coronary angiography performed through trans-radial access
Trans-femoralOther
Coronary angiography performed through trans-femoral access
| Study group | Role | What they receive |
|---|---|---|
| Trans-radial access | Active comparator | Coronary angiography performed through trans-radial access Receives: Other: Trans-radial |
| Trans-femoral access | Active comparator | Coronary angiography performed through trans-femoral access Receives: Other: Trans-femoral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient radiation exposure (mGy)
Patient radiation exposure (mGy)
Measured: during coronary angiography
Secondary outcomes (1)
Physician radiation exposure (in uSv)
Physician radiation exposure (in uSv)
Measured: during coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Ionizing RadiationStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Ernesto Dornelles
- Responsible party
- Sponsor
- Investigators
- Cristiano O Cardoso, MD, MSc, Study chair, Instituto de Cardiologia do Rio Grande do SulLuis M Yordi, MD, Study director, Hospital Ernesto DornellesClaudio V Moraes, MD, Principal investigator, Insituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794325
- Sponsor's protocol ID
- UP 4786/12
- Acronym
- EXPERT
- Status last verified
- Sep 2014
- First submitted
- 15 Feb 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT01794325
- Acronym / sponsor ID
- EXPERT / UP 4786/12
- Keywords
- Occupational radiation exposure, Transradial approach, Transfemoral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital Ernesto Dornelles
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Feb 2013 (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.
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.
The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-radial access | Active comparator | Other: Trans-radialCoronary angiography performed through trans-radial access |
| Trans-femoral access | Active comparator | Other: Trans-femoralCoronary angiography performed through trans-femoral access |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for a elective coronary angiography
- Eligible for either transfemoral or transradial approach
- Accept to sign the written consent form (WCF)
Key exclusion criteria (5 listed)
- Refusal to sign the WCF
- End stage renal failure
- Urgency/Emergency procedure
- Contraindication to perform both coronary and left ventricle angiogram
- Necessity of another vascular angiogram during coronary angiography
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 |
|---|---|---|
| Trans-radialCoronary angiography performed through trans-radial access | Other | Trans-radial access |
| Trans-femoralCoronary angiography performed through trans-femoral access | Other | Trans-femoral access |
Primary outcome
Patient radiation exposure (mGy)
Time frame: during coronary angiography
Patient radiation exposure (mGy)
1 secondary outcome
Physician radiation exposure (in uSv)
Time frame: during coronary angiography
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 17 Sep 2014.
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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.
Cristiano O Cardoso, MD, MSc study chair
Instituto de Cardiologia do Rio Grande do Sul
Luis M Yordi, MD study director
Hospital Ernesto Dornelles
Claudio V Moraes, MD principal investigator
Insituto de Cardiologia do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-radial and Trans-femoral in people with Exposure to Ionizing Radiation and Coronary Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul 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 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 17 Sep 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 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. 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?
Patient radiation exposure (mGy) (time frame: during coronary angiography). 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 17 Sep 2014.