NCT05833516

Brief 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 comparable, or the same operator radiation exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

April 17, 2023

Last Update Submit

March 18, 2025

Conditions

Radiation Exposure

Keywords

prospectiverandomizedradiation doseoperator exposurecardiac catheterization

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    During Cardiac Catheterization

Secondary Outcomes (4)

  • Dose Area product (DAP)

    During Cardiac Catheterization

  • Flouroscopy time

    During Cardiac Catheterization

  • mGy

    During Cardiac Catheterization

  • Subclavian tortuosity (Yes/no)

    During Cardiac Catheterization

Study Arms (2)

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.

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.

Diagnostic Test: Cardiac Catheterization

Interventions

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.

Hyperadducted Right Radial Arm (HARRA)Left Arm Drag over technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

• Patients seen at Maimonides Medical Center, who meet the inclusion criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (10)

  • 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.

    PMID: 21167351BACKGROUND

  • Dominici 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.

    PMID: 23343690BACKGROUND

  • Kado 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.

    PMID: 24954573BACKGROUND

  • Sciahbasi 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.

    PMID: 29421003BACKGROUND

  • Sciahbasi 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.

    PMID: 28330794BACKGROUND

  • De 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.

    PMID: 24331866BACKGROUND

  • Bull JP. Trauma audit. Arch Emerg Med. 1989 Dec;6(4):288-9. doi: 10.1136/emj.6.4.288-b. No abstract available.

    PMID: 2610809BACKGROUND

  • 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.

    PMID: 26210808BACKGROUND

  • Fu 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.

    PMID: 26150704BACKGROUND

  • Casazza 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.

    PMID: 40104858DERIVED

MeSH Terms

Interventions

Cardiac Catheterization

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 27, 2023

Study Start

November 10, 2022

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

US(1)