Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal radial artery access | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Thumb and Forefinger Pinch Strength Test | Hand function: Thumb and forefinger pinch strength (kg) | 1 year |
| Hand Grip Strength Test | Hand grip strength test (kg) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention Using the Radial Artery | Patients who required re-intervention using the radial artery up to 1 year following the initial intervention | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37889176 | Derived | 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. | |
| 34637140 |
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients enrolled and randomized in the DIPRA trial
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Patients who completed 1 year of follow up | Posted | Median | Inter-Quartile Range | DASH Score change from baseline | 1 year |
|
1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure with hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hale | Baylor Scott and White Resarch Institute | 469-814-4845 | sarah.hale@bswhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2022 | Nov 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2020 | Nov 16, 2023 | ICF_001.pdf |
Not provided
Prospective, randomized, single-center clinical trial
Not provided
Not provided
Not provided
Not provided
| Proximal radial artery surgery | Procedure | 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. |
|
| 1 year |
| Derived |
| Flumignan 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Inter-Quartile Range | kg/m2 |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypercholesteremia | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Prior Myocardial Infarction | Count of Participants | Participants |
|
| Prior CABG | Count of Participants | Participants |
|
| Prior PCI | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Thumb and Forefinger Pinch Strength Test | Hand function: Thumb and forefinger pinch strength (kg) | Patients who completed 1 year of follow up | Posted | Median | Inter-Quartile Range | pinch grip(kg) change from baseline | 1 year |
|
|
|
| Primary | Hand Grip Strength Test | Hand grip strength test (kg) | Patients who completed 1 year of follow up | Posted | Median | Inter-Quartile Range | hand grip (kg) change from baseline | 1 month |
|
|
|
| Secondary | Re-intervention Using the Radial Artery | Patients who required re-intervention using the radial artery up to 1 year following the initial intervention | Patients who completed 1 year of follow up | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Radial Artery Occlusion | Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access | Patients who completed 1 year of follow up | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 1 |
| 150 |
| 4 |
| 150 |
| 0 |
| 150 |
| EG001 | 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. | 1 | 150 | 1 | 150 | 0 | 150 |
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Orthopedic Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gross hematuria | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| No Radial Artery Occlusion |
|