Distal vs. Forearm Radial Artery Access

Study Overview
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Brief Summary
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The Distal Radial Access (DRA) to the coronaries has emerged recently. It's done via the distal radial artery in the radial fossa, which is known as the snuff-box. The rationale of conducting this research is to assess this new access advantages and disadvantages, in comparison with the standard conventional forearm radial access and examine if it's worthy to be a future alternative method for coronary angiography. It aims to randomly compare between the new distal radial access via the snuffbox and the conventional forearm radial access for percutaneous coronary angiography and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time, and convenience of the patients and operators. Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery in the forearm. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours after the procedure.

Official Title
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Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial

Conditions
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Coronary Artery Disease, Angina, Unstable, Angina, Stable, Non STEMI, Acute Coronary Syndrome, ST-segment Elevation Myocardial Infarction (STEMI), Non ST Segment Elevation Myocardial Infarction, Atheroscleroses, Coronary, Atherosclerotic Heart Disease With Ischemic Chest Pain, Chest Pain, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
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* Procedure: distal radial artery access in coronary angiography and angioplasty
* Procedure: Forearm radial artery access in coronary angiography and angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who agree to participate in the study and sign the consent form. Patients with an indication for coronary catheterization Clinically stable patients Patients with palpable pulses on both access sites of the radial artery. Exclusion Criteria: Patients with STEMI Patients with radial AV shunt for hemodialysis Patients with previous CABG using radial artery Patients with previous CABG using LIMA, RIMA or both. Patients with Renaud phenomenon or lymphedema

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal Radial<br>Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand. | Procedure: distal radial artery access in coronary angiography and angioplasty<br>* The patient grasps his thumb towards the palm to bring the radial artery up to the surface. The left hand is set on the right side of the groin toward the operator, who stands on the right side, with the dorsal surface of hand upwards. Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the distal radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, Safe Guard, is used for hemostasis.<br>|
| Active Comparator: Forearm Radial<br>Patients who undergo conventional coronary catheterization by accessing the forearm radial artery. | Procedure: Forearm radial artery access in coronary angiography and angioplasty<br>* The right hand is set in the anatomical position, with the anterior surface of arm face upwards. Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the forearm radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, TR band, is used for hemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion | Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. | Within 24 hours after the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture Time | Which is time from first attempt to puncture to the successful one in seconds | During the procedure | 
| Puncture Attempts | Which is the number of puncture attempts from first one until the successful one (maximum 6) | During the procedure | 
| Procedure Duration | In minutes from the insertion of the sheath to its exertion. | During the procedure | 
| Radiation Duration | Which is measured by the radiological device in minutes. | During the procedure | 
| Radiology Dose | Which is measured by the radiological device in mGy. | During the procedure | 
| Compression hemostasis time | The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes. | Up to 240 minutes after band placement | 
| Arterial spasm | Which is assessed by the operator if present or absent in terms of the difficulty in inserting the wire at the time of the procedures. of the procedure. | During the procedure | 
| Hematoma and bleeding complications | It is defined by EASY hematoma scale. | Within 24 hours after the procedure | 
| Ischemic changes to the hand | It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis. | Within 24 hours after the procedure | 
| Crossover (failure to puncture) | It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access | During the procedure | 
| Procedural pain | Assessed by numerical rating scale (NRS) for pain, which is an 10 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain. | During the procedure | 
| Post-procedural pain | Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain. | Within 24 hours after the procedure | 
| Rare complications | Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation. | Within 24 hours after the procedure | 
| Radial Artery Occlusion on follow up | Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours. | After 2 weeks of the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial artery, safeguard, distal radial access, coronary arteries, radial artery occlusion, angioplasty, cardiac catheterization, coronary angiography, coronary angioplasty, snuff-box, snuffbox, snuff box, radial fossa, distal radial artery, distal radial angiography, radial access, angiography, distal radial, radial, randomized controlled trial, left distal radial artery, Percutaneous Coronary Intervention, forearm radial access, forearm radial artery, coronary catheterization, catheterization, left distal radial, coronary artery disease, radial vs distal