Radiation ExposureHARRANCT05833516
Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique
An observational study of Radiation Exposure, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Cardiac Catheterization
- How many people
- 534 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 23 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: • Patients seen at Maimonides Medical Center, who meet the inclusion criteria
Who may be able to join
- All the Cardiac catheterization laboratory physician operators who consent to participate in the study
- Patients of any sex and gender.
- Age > 18 years old.
- Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings
Who cannot join
- History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
- Patients undergoing elective PCI (Percutaneous Coronary Intervention)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.
Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.
Read the detailed description
Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.
Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.
This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, \& contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.
- Conditions
- Radiation Exposure
- Being tested
- Cardiac Catheterization
- Keywords
- prospective, randomized, radiation dose, operator exposure, cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CatheterizationDiagnostic test
The cardiac catheterization is an invasive procedure in which right or left radial artery of patient will be accessed to obtain cardiac angiogram. The study participants are both operators and patients by obtaining the amount of radiation they both were exposed in these two different arm techniques.
The patient will have to do nothing more than following the existing standard protocols which are followed nationwide. As, the radiation exposure to patients are already measured in the software itself. The operators however would be wearing radiation badges in 4 different anatomic locations to record radiation data for study.
| Study group | Role | What they receive |
|---|---|---|
| Hyperadducted Right Radial Arm (HARRA) | The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to hyperadducted right radial arm will be recorded for primary outcome. Receives: Diagnostic Test: Cardiac Catheterization | |
| Left Arm Drag over technique | The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to Left Arm drag over technique will be recorded for primary outcome. Receives: Diagnostic Test: Cardiac Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator radiation exposure
The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected
Measured: During Cardiac Catheterization
Normalized Dose
The second primary endpoint is Normalized dose, measured by dividing cumulative dose by dose area product (CD/DAP) and entered into query sheet then logged into an Excel spreadsheet.
Measured: During Cardiac Catheterization
Secondary outcomes (4)
Dose Area product (DAP)
Dose area product (DAP) is a quantity used in assessing the radiation risk from diagnostic X-ray examinations and interventional procedures. It is defined as the absorbed dose multiplied by the area irradiated, expressed in gray-centimetres squared.
Measured: During Cardiac Catheterization
Flouroscopy time
Duration of flouroscopy also known as duration of radiation
Measured: During Cardiac Catheterization
mGy
mGy is the unit of absorbed radiation dose
Measured: During Cardiac Catheterization
Subclavian tortuosity (Yes/no)
The anatomic complexity in subclavian artery which causes difficulty in performing cardiac catheterization through radial access.
Measured: During Cardiac Catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start10 Nov 2022
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833516
- Sponsor's protocol ID
- #2022-05-19
- Acronym
- HARRA
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending decision of research committee and any request generated to share data.
Publications
Sciahbasi A, Romagnoli E, Burzotta F, Trani C, Sarandrea A, Summaria F, Pendenza G, Tommasino A, Patrizi R, Mazzari M, Mongiardo R, Lioy E. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011 Jan;161(1):172-9. doi: 10.1016/j.ahj.2010.10.003.
PubMed 21167351Dominici M, Diletti R, Milici C, Bock C, Placanica A, D'Alessandro G, Arrivi A, Italiani M, Buono E, Boschetti E. Operator exposure to x-ray in left and right radial access during percutaneous coronary procedures: OPERA randomised study. Heart. 2013 Apr;99(7):480-4. doi: 10.1136/heartjnl-2012-302895. Epub 2013 Jan 23.
PubMed 23343690Kado H, Patel AM, Suryadevara S, Zenni MM, Box LC, Angiolillo DJ, Bass TA, Guzman LA. Operator radiation exposure and physical discomfort during a right versus left radial approach for coronary interventions: a randomized evaluation. JACC Cardiovasc Interv. 2014 Jul;7(7):810-6. doi: 10.1016/j.jcin.2013.11.026. Epub 2014 Jun 18.
PubMed 24954573Sciahbasi A, Frigoli E, Sarandrea A, Calabro P, Rubartelli P, Cortese B, Tomassini F, Zavalloni D, Tebaldi M, Calabria P, Rigattieri S, Zingarelli A, Sardella G, Lupi A, Rothenbuhler M, Heg D, Valgimigli M. Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study. Am Heart J. 2018 Feb;196:113-118. doi: 10.1016/j.ahj.2017.10.014. Epub 2017 Oct 28.
PubMed 29421003Sciahbasi A, Frigoli E, Sarandrea A, Rothenbuhler M, Calabro P, Lupi A, Tomassini F, Cortese B, Rigattieri S, Cerrato E, Zavalloni D, Zingarelli A, Calabria P, Rubartelli P, Sardella G, Tebaldi M, Windecker S, Juni P, Heg D, Valgimigli M. Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RAD-Matrix Trial. J Am Coll Cardiol. 2017 May 23;69(20):2530-2537. doi: 10.1016/j.jacc.2017.03.018. Epub 2017 Mar 18.
PubMed 28330794De Rosa S, Torella D, Caiazzo G, Giampa S, Indolfi C. Left radial access for percutaneous coronary procedures: from neglected to performer? A meta-analysis of 14 studies including 7,603 procedures. Int J Cardiol. 2014 Jan 15;171(1):66-72. doi: 10.1016/j.ijcard.2013.11.046. Epub 2013 Nov 23.
PubMed 24331866Bull JP. Trauma audit. Arch Emerg Med. 1989 Dec;6(4):288-9. doi: 10.1136/emj.6.4.288-b. No abstract available.
PubMed 2610809Pancholy 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 26210808Fu Q, Hu H, Wang D, Chen W, Tan Z, Li Q, Chen B. Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction. Clin Interv Aging. 2015 Jun 24;10:1003-8. doi: 10.2147/CIA.S81568. eCollection 2015.
PubMed 26150704Casazza R, Malik B, Hashmi A, Fogel J, Montagna E, Frankel R, Borgen E, Ayzenberg S, Friedman M, Moskovits N, Verma S, Meng J, Chang N, Huang Y, Rodriguez C, Chera HH, Raj S, Chaterjee S, Gibson D, Palacios A, Agarwal C, Nene MV, Shani J. Operator Radiation Exposure Comparing the Left Radial Artery Approach and a Uniform Hyper-Adducted Right Radial Artery Approach: The HARRA Study. Circ Cardiovasc Interv. 2025 Apr;18(4):e014602. doi: 10.1161/CIRCINTERVENTIONS.124.014602. Epub 2025 Mar 19.
PubMed 40104858
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.
- ClinicalTrials.gov ID
- NCT05833516
- Acronym / sponsor ID
- HARRA / #2022-05-19
- Conditions
- Radiation Exposure
- Keywords
- prospective, randomized, radiation dose, operator exposure, cardiac catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 27 Apr 2023 (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.
Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.
Detailed description
Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.
Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.
This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, \& contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperadducted Right Radial Arm (HARRA) | – | Diagnostic Test: Cardiac CatheterizationThe primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to hyperadducted right radial arm will be recorded for primary outcome. |
| Left Arm Drag over technique | – | Diagnostic Test: Cardiac CatheterizationThe primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to Left Arm drag over technique will be recorded for primary outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- • Patients seen at Maimonides Medical Center, who meet the inclusion criteria
Key inclusion criteria (4 listed)
- All the Cardiac catheterization laboratory physician operators who consent to participate in the study
- Patients of any sex and gender.
- Age > 18 years old.
- Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings
Key exclusion criteria (2 listed)
- History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
- Patients undergoing elective PCI (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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CatheterizationThe cardiac catheterization is an invasive procedure in which right or left radial artery of patient will be accessed to obtain cardiac angiogram. The study participants are both operators and patients by obtaining the amount of radiation they both were exposed in these two different arm techniques. The patient will have to do nothing more than following the existing standard protocols which are followed nationwide. As, the radiation exposure to patients are already measured in the software itself. The operators however would be wearing radiation badges in 4 different anatomic locations to record radiation data for study. | Diagnostic test | Hyperadducted Right Radial Arm (HARRA), Left Arm Drag over technique |
Primary outcome
Operator radiation exposure
Time frame: During Cardiac Catheterization
The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected
Normalized Dose
Time frame: During Cardiac Catheterization
The second primary endpoint is Normalized dose, measured by dividing cumulative dose by dose area product (CD/DAP) and entered into query sheet then logged into an Excel spreadsheet.
4 secondary outcomes
Dose Area product (DAP)
Time frame: During Cardiac Catheterization
Flouroscopy time
Time frame: During Cardiac Catheterization
mGy
Time frame: During Cardiac Catheterization
Subclavian tortuosity (Yes/no)
Time frame: During Cardiac Catheterization
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 19 Mar 2025.
- Background: PubMed 21167351Sciahbasi A, Romagnoli E, Burzotta F, Trani C, Sarandrea A, Summaria F, Pendenza G, Tommasino A, Patrizi R, Mazzari M, Mongiardo R, Lioy E. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011 Jan;161(1):172-9. doi: 10.1016/j.ahj.2010.10.003.
- Background: PubMed 23343690Dominici M, Diletti R, Milici C, Bock C, Placanica A, D'Alessandro G, Arrivi A, Italiani M, Buono E, Boschetti E. Operator exposure to x-ray in left and right radial access during percutaneous coronary procedures: OPERA randomised study. Heart. 2013 Apr;99(7):480-4. doi: 10.1136/heartjnl-2012-302895. Epub 2013 Jan 23.
- Background: PubMed 24954573Kado H, Patel AM, Suryadevara S, Zenni MM, Box LC, Angiolillo DJ, Bass TA, Guzman LA. Operator radiation exposure and physical discomfort during a right versus left radial approach for coronary interventions: a randomized evaluation. JACC Cardiovasc Interv. 2014 Jul;7(7):810-6. doi: 10.1016/j.jcin.2013.11.026. Epub 2014 Jun 18.
- Background: PubMed 29421003Sciahbasi A, Frigoli E, Sarandrea A, Calabro P, Rubartelli P, Cortese B, Tomassini F, Zavalloni D, Tebaldi M, Calabria P, Rigattieri S, Zingarelli A, Sardella G, Lupi A, Rothenbuhler M, Heg D, Valgimigli M. Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study. Am Heart J. 2018 Feb;196:113-118. doi: 10.1016/j.ahj.2017.10.014. Epub 2017 Oct 28.
- Background: PubMed 28330794Sciahbasi A, Frigoli E, Sarandrea A, Rothenbuhler M, Calabro P, Lupi A, Tomassini F, Cortese B, Rigattieri S, Cerrato E, Zavalloni D, Zingarelli A, Calabria P, Rubartelli P, Sardella G, Tebaldi M, Windecker S, Juni P, Heg D, Valgimigli M. Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RAD-Matrix Trial. J Am Coll Cardiol. 2017 May 23;69(20):2530-2537. doi: 10.1016/j.jacc.2017.03.018. Epub 2017 Mar 18.
- Background: PubMed 24331866De Rosa S, Torella D, Caiazzo G, Giampa S, Indolfi C. Left radial access for percutaneous coronary procedures: from neglected to performer? A meta-analysis of 14 studies including 7,603 procedures. Int J Cardiol. 2014 Jan 15;171(1):66-72. doi: 10.1016/j.ijcard.2013.11.046. Epub 2013 Nov 23.
- Background: PubMed 2610809Bull JP. Trauma audit. Arch Emerg Med. 1989 Dec;6(4):288-9. doi: 10.1136/emj.6.4.288-b. No abstract available.
- Background: 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.
- Background: PubMed 26150704Fu Q, Hu H, Wang D, Chen W, Tan Z, Li Q, Chen B. Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction. Clin Interv Aging. 2015 Jun 24;10:1003-8. doi: 10.2147/CIA.S81568. eCollection 2015.
- Derived from this study: PubMed 40104858Casazza R, Malik B, Hashmi A, Fogel J, Montagna E, Frankel R, Borgen E, Ayzenberg S, Friedman M, Moskovits N, Verma S, Meng J, Chang N, Huang Y, Rodriguez C, Chera HH, Raj S, Chaterjee S, Gibson D, Palacios A, Agarwal C, Nene MV, Shani J. Operator Radiation Exposure Comparing the Left Radial Artery Approach and a Uniform Hyper-Adducted Right Radial Artery Approach: The HARRA Study. Circ Cardiovasc Interv. 2025 Apr;18(4):e014602. doi: 10.1161/CIRCINTERVENTIONS.124.014602. Epub 2025 Mar 19.
- Individual participant dataSharing planned: Undecided. Pending decision of research committee and any request generated to share data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiation Exposure, run by Maimonides Medical Center at 1 site in United States.
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 4 inclusion and 2 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 19 Mar 2025. 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 United States. 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?
Operator radiation exposure (time frame: During Cardiac Catheterization). The study lists 2 primary outcomes in all. 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 NCT05833516, which also lists 10 linked publications.
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 19 Mar 2025.