DIstal vs Proximal Radial Artery Access for Cath

Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04318990

Acronym

DIPRA

Enrollment

300

Registered

2020-03-24

Start date

2020-03-06

Completion date

2022-12-31

Last updated

2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angiography, Coronary Angioplasty

Brief summary

This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.

Detailed description

Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization. Hand function will be assessed by: * QuickDASH questionnaire * Hand grip test * Thumb forefinger pinch test utilizing a pinch gauge Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.

Interventions

PROCEDUREDistal radial artery access

Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.

PROCEDUREProximal radial artery surgery

Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Prospective, randomized, single-center clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years. 2. The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound. 3. Patient should be able to comply with the protocol. 4. Provide written informed consent before study participation

Exclusion criteria

1. Obligatory femoral or forearm radial access 2. Previous ipsilateral forearm radial artery occlusion. 3. Patient on therapeutic oral anticoagulation. 4. Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands. 5. Enrolment in another study that competes or interferes with this study. 6. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests. 7. Subject with planned complex PCI or procedure necessitating multiple intervention. 8. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 9. History of stroke with residual deficit that affects hand function. 10. Previous radial artery catheterization within 1 year.

Design outcomes

Primary

Measure	Time frame	Description
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)	1 year	Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Thumb and Forefinger Pinch Strength Test	1 year	Hand function: Thumb and forefinger pinch strength (kg)
Hand Grip Strength Test	1 month	Hand grip strength test (kg)

Secondary

Measure	Time frame	Description
Re-intervention Using the Radial Artery	1 year	Patients who required re-intervention using the radial artery up to 1 year following the initial intervention
Radial Artery Occlusion	1 year	Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access

Countries

United States

Participant flow

Recruitment details

Patients who were undergoing a cardiac catheterization at Baylor Scott and White- The Heart Hospital Plano were considered for enrollment in the trial. Enrollment started in March 2020 and completed in December 2021.

Pre-assignment details

Subjects who met the screening inclusion criteria and have not met any of the trial exclusion criteria were included in the study. Screening assessments were conducted through review of medical records and by interview after informed consent was signed. In addition, a mandatory screening assessment for research purposes included assessing the patency of the pRA and dRA using palpation first, and if both are palpable then doppler ultrasound.

Participants by arm

Arm	Count
Distal Radial Artery Access Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees. Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.	150
Proximal Radial Artery Access Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization. Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.	150
Total	300

Baseline characteristics

Characteristic	Distal Radial Artery Access	Proximal Radial Artery Access	Total
Age, Continuous	65.9 years STANDARD_DEVIATION 8.7	67.3 years STANDARD_DEVIATION 10.5	66.6 years STANDARD_DEVIATION 9.6
BMI	29.9 kg/m2	30.1 kg/m2	30.0 kg/m2
Diabetes Mellitus	51 Participants	45 Participants	96 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	5 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants	143 Participants	290 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	3 Participants
Hypercholesteremia	27 Participants	29 Participants	56 Participants
Hypertension	112 Participants	120 Participants	232 Participants
Prior CABG	3 Participants	3 Participants	6 Participants
Prior Myocardial Infarction	23 Participants	16 Participants	39 Participants
Prior PCI	25 Participants	31 Participants	56 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	8 Participants	5 Participants	13 Participants
Race (NIH/OMB) Black or African American	8 Participants	9 Participants	17 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants	3 Participants	8 Participants
Race (NIH/OMB) White	128 Participants	132 Participants	260 Participants
Sex: Female, Male Female	31 Participants	43 Participants	74 Participants
Sex: Female, Male Male	119 Participants	107 Participants	226 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 150	1 / 150
other Total, other adverse events	0 / 150	0 / 150
serious Total, serious adverse events	4 / 150	1 / 150

Outcome results

Primary