Coronary AngiographyDIPRANCT04318990
DIstal vs Proximal Radial Artery Access for Cath
A study testing Distal radial artery access and Proximal radial artery surgery in people with Coronary Angiography and Coronary Angioplasty, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Coronary Angioplasty
- What is being tested?
- Distal radial artery access and Proximal radial artery surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation
Who cannot join
- Obligatory femoral or forearm radial access
- Previous ipsilateral forearm radial artery occlusion.
- Patient on therapeutic oral anticoagulation.
- Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
- Enrolment in another study that competes or interferes with this study.
- Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
Show all 10Show fewer
- Subject with planned complex PCI or procedure necessitating multiple intervention.
- 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.
- History of stroke with residual deficit that affects hand function.
- Previous radial artery catheterization within 1 year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
About this study
Official title: Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
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.
Read the 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.
- Conditions
- Coronary Angiography, Coronary Angioplasty
- Being tested
- Distal radial artery access, Proximal radial artery surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial artery accessProcedure or 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.
Proximal radial artery surgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| Distal radial artery access | Experimental | 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. Receives: Procedure: Distal radial artery access |
| Proximal radial artery access | Active comparator | 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. Receives: Procedure: Proximal radial artery surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Measured: 1 year
Thumb and Forefinger Pinch Strength Test
Hand function: Thumb and forefinger pinch strength (kg)
Measured: 1 year
Hand Grip Strength Test
Hand grip strength test (kg)
Measured: 1 month
Secondary outcomes (2)
Re-intervention Using the Radial Artery
Patients who required re-intervention using the radial artery up to 1 year following the initial intervention
Measured: 1 year
Radial Artery Occlusion
Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start6 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, single-center clinical trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318990
- Sponsor's protocol ID
- 019-504 DIPRA
- Acronym
- DIPRA
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, McCracken J, Smith A, Kelavkar U, Hale S, Van Zyl J, McCoy SL, Lanfear AT, Banwait JK, Ravindranathan P, Chionh K, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 30-Day Outcomes of the DIPRA Study. J Am Heart Assoc. 2023 Nov 7;12(21):e030774. doi: 10.1161/JAHA.123.030774. Epub 2023 Oct 27.
PubMed 37889176Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
- ClinicalTrials.gov ID
- NCT04318990
- Acronym / sponsor ID
- DIPRA / 019-504 DIPRA
- Conditions
- Coronary Angiography, Coronary Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Distal radial artery access | Experimental | Procedure: Distal radial artery accessWrist 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. |
| Proximal radial artery access | Active comparator | Procedure: Proximal radial artery surgeryHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation
Key exclusion criteria (10 listed)
- Obligatory femoral or forearm radial access
- Previous ipsilateral forearm radial artery occlusion.
- Patient on therapeutic oral anticoagulation.
- Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
- Enrolment in another study that competes or interferes with this study.
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 |
|---|---|---|
| Distal radial artery accessPatients 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. | Procedure or surgery | Distal radial artery access |
| Proximal radial artery surgeryPatients 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. | Procedure or surgery | Proximal radial artery access |
Primary outcome
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
Time frame: 1 year
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Thumb and Forefinger Pinch Strength Test
Time frame: 1 year
Hand function: Thumb and forefinger pinch strength (kg)
Hand Grip Strength Test
Time frame: 1 month
Hand grip strength test (kg)
2 secondary outcomes
Re-intervention Using the Radial Artery
Time frame: 1 year
Radial Artery Occlusion
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37889176Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, McCracken J, Smith A, Kelavkar U, Hale S, Van Zyl J, McCoy SL, Lanfear AT, Banwait JK, Ravindranathan P, Chionh K, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 30-Day Outcomes of the DIPRA Study. J Am Heart Assoc. 2023 Nov 7;12(21):e030774. doi: 10.1161/JAHA.123.030774. Epub 2023 Oct 27.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
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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?
A study testing Distal radial artery access and Proximal radial artery surgery in people with Coronary Angiography and Coronary Angioplasty, run by Baylor Research Institute 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 10 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 3 May 2024. 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?
Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) (time frame: 1 year). The study lists 3 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 NCT04318990, which also lists 2 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 3 May 2024.