Exposure to Ionizing RadiationREVERENCT01677481
Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial
An observational study of Exposure to Ionizing Radiation, run by Total Cardiovascular Solutions at 1 site in India.
Trial summary
The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Exposure to Ionizing Radiation
- How many people
- 1,500 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Aug 2014
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for diagnostic coronary angiography
Who may be able to join
- All patients undergoing diagnostic coronary angiography
Who cannot join
- non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial.
The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site
Read the detailed description
Patients referred for coronary angiography will be randomized to either left radial, right radial or femoral arterial access sites, and the coronary angiogram will be performed in a standard fashion, including left ventriculography. Radiation exposure parameters including Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be recorded. Operator experience as well as demographic data will be recorded.
- Conditions
- Exposure to Ionizing Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femoral | Coronary angiography procedures performed using transfemoral access | |
| Left radial access | Coronary angiography procedures performed using left radial access site. | |
| Right radial Access | Coronary angiography procedures performed using Right radial access site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air Kerma
The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Total Cardiovascular Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tejas M Patel, MD, DM, Principal investigator, Chief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677481
- Sponsor's protocol ID
- MIL/IMRC/RP/TP/10/2010
- Acronym
- REVERE
- Status last verified
- Mar 2016
- First submitted
- 23 Aug 2012
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.
PubMed 26210808
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial.
- ClinicalTrials.gov ID
- NCT01677481
- Acronym / sponsor ID
- REVERE / MIL/IMRC/RP/TP/10/2010
- Conditions
- Exposure to Ionizing Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Total Cardiovascular SolutionsUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Sep 2012 (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 study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site
Detailed description
Patients referred for coronary angiography will be randomized to either left radial, right radial or femoral arterial access sites, and the coronary angiogram will be performed in a standard fashion, including left ventriculography. Radiation exposure parameters including Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be recorded. Operator experience as well as demographic data will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral | – | –Coronary angiography procedures performed using transfemoral access |
| Left radial access | – | –Coronary angiography procedures performed using left radial access site. |
| Right radial Access | – | –Coronary angiography procedures performed using Right radial access site. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for diagnostic coronary angiography
Key inclusion criteria (1 listed)
- All patients undergoing diagnostic coronary angiography
Key exclusion criteria (1 listed)
- non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Air Kerma
Time frame: 1 day
The investigators will measure Air Kerma (cumulative) at the end of the procedure of 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 15 Mar 2016.
- Derived from this study: PubMed 26210808Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.
- 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.
Tejas M Patel, MD, DM principal investigator
Chief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Ionizing Radiation, run by Total Cardiovascular Solutions at 1 site in India.
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 1 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 15 Mar 2016. 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 India. 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?
Air Kerma (time frame: 1 day). 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 NCT01677481, which also lists 1 linked publication.
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 15 Mar 2016.