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Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure.
The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month.
Hand sensory and motor dysfunction will be assessed by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal radial artery access group | Experimental | Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access. |
|
| Conventional radial artery access group | Active Comparator | Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional radial artery access | Procedure | Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization. |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Numbness | Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure. | 24 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve Injury | Number of participants with the nerve injury is detected using high-frequent ultrasound or electromyography at 24 hours after procedure, and patients with nerve injury at 1 month follow-up will be recorded. | 24 hours and 1 month after procedure |
| Thumb and Index Finger Pinch Test |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Li, Ms | Contact | +86-0519-85579192 | lifeng198boy@126.com | |
| Gaojun Cai, MD | Contact | +86-0519-85579193 | caigaojun@wjrmyy.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gaojun Cai, MD | Cardiovascular department, Changzhou Wujin People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25819177 | Result | van Leeuwen MA, van Mieghem NM, Lenzen MJ, Selles RW, Hoefkens MF, Zijlstra F, van Royen N. The effect of transradial coronary catheterization on upper limb function. JACC Cardiovasc Interv. 2015 Apr 20;8(4):515-23. doi: 10.1016/j.jcin.2014.10.025. Epub 2015 Mar 26. | |
| 35595672 | Result | Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17. |
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Prospective, randomized, single-center clinical trial
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| Distal radial artery access | Procedure | Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization. |
|
Thumb and forefinger lateral pinch strength (kg) |
| 24 hours before and after procedure, 1 month after procedure |
| Hand Grip Test | Hand grip strength test (kg) | 24 hours before and after procedure, 1 month after procedure |
| Late-term Hand Numbness | Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure. | 1 month after procedure |
| Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100) | Upper extremity dysfunction questionnaire. Scores range from 0 to 100, with higher scores indicating greater dysfunction. | 24 hours before procedure and 1 month after procedure |
| Visual Analogue Scale (VAS) Scale (0-10) | Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity. | 24 hours after procedure |
| Hand Paresthesia | Number of participants with the hand paresthesia is assessed using monofilament test and/or two-point discrimination test at 24 hours after procedure, and patients with hand paresthesia at 1 month follow-up will be recorded. | 24 hours and 1 month after procedure |
| Hand Clumsiness | Number of participants with the hand clumsiness at 24 hours after procedure, and patients with hand clumsiness at 1 month follow-up will be recorded. | 24 hours and 1 month after procedure |
| 38353242 | Result | Tehrani BN, Sherwood MW, Damluji AA, Epps KC, Bakhshi H, Cilia L, Dassanayake I, Eltebaney M, Gattani R, Howard E, Kepplinger D, Ofosu-Somuah A, Batchelor WB. A Randomized Comparison of Radial Artery Intimal Hyperplasia Following Distal Versus Proximal Transradial Access for Coronary Angiography: PRESERVE RADIAL. J Am Heart Assoc. 2024 Feb 20;13(4):e031504. doi: 10.1161/JAHA.123.031504. Epub 2024 Feb 14. |
| 35911661 | Result | Daralammouri Y, Nazzal Z, Mosleh YS, Abdulhaq HK, Khayyat ZY, Hamshary YE, Azamtta M, Ghanim A, Awwad F, Majadla S, Maree M, Hamaida J, Ismail Y. Distal Radial Artery Access in comparison to Forearm Radial Artery Access for Cardiac Catheterization: A Randomized Controlled Trial (DARFORA Trial). J Interv Cardiol. 2022 Jul 15;2022:7698583. doi: 10.1155/2022/7698583. eCollection 2022. |
| 38331793 | Result | Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7. |
| 39474765 | Result | Babunashvili AM, Pancholy S, Zulkarnaev AB, Kaledin AL, Kochanov IN, Korotkih AV, Kartashov DS, Babunashvili MA. Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study. Catheter Cardiovasc Interv. 2024 Dec;104(7):1396-1405. doi: 10.1002/ccd.31271. Epub 2024 Oct 30. |
| 35595673 | Result | Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17. |
| 38432334 | Result | Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, Hale S, Zyl JV, Settele RM, Gonzalez OR, Ventura SJ, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 1-Year Outcomes. Am J Cardiol. 2024 Jun 1;220:102-110. doi: 10.1016/j.amjcard.2024.02.036. Epub 2024 Mar 2. |
| 38137677 | Result | Kozinski L, Orzalkiewicz Z, Dabrowska-Kugacka A. Feasibility and Safety of the Routine Distal Transradial Approach in the Anatomical Snuffbox for Coronary Procedures: The ANTARES Randomized Trial. J Clin Med. 2023 Dec 11;12(24):7608. doi: 10.3390/jcm12247608. |
| 37842393 | Result | Gupta M, Kumar V, Rahman MW, Srivastava S, Pandey U, Sinha SK. Comparison Between Distal Trans-radial Access and Conventional Trans-radial Access for Coronary Angiography. Cureus. 2023 Sep 12;15(9):e45081. doi: 10.7759/cureus.45081. eCollection 2023 Sep. |