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Trial record 77 of 172 for:    "Heart Disease" | "Heparin"

Distal Radial Artery vs. Forearm Radial Artery For Cardiac Catheterization (DRAvsFRA)

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ClinicalTrials.gov Identifier: NCT04125992
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yunis Daralammouri, An-Najah National University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina, Unstable Angina, Stable Non STEMI Non ST Segment Elevation Myocardial Infarction Acute Coronary Syndrome Atheroscleroses, Coronary Atherosclerotic Heart Disease With Ischemic Chest Pain Chest Pain Myocardial Infarction Myocardial Ischemia ST-segment Elevation Myocardial Infarction (STEMI) Procedure: distal radial artery access in coronary angiography and angioplasty Procedure: Forearm radial artery access in coronary angiography and angioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Coronary Angiography and Angioplasty Access Sites, Through the Left Distal Radial Artery (ldRA) at the Snuff-box and the Forearm Radial Artery (FRA), in Patients With Coronary Artery Disease; A Pilot RCT
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Distal Radial
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

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.


Active Comparator: Forearm Radial
Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.
Procedure: Forearm radial artery access in coronary angiography and angioplasty

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.





Primary Outcome Measures :
  1. Radial artery occlusion [ Time Frame: Within 24 hours after the procedure. ]
    Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.


Secondary Outcome Measures :
  1. Puncture Time [ Time Frame: During the procedure ]
    Which is time from first attempt to puncture to the successful one in seconds

  2. Puncture Attempts [ Time Frame: During the procedure ]
    Which is the number of puncture attempts from first one until the successful one (maximum 6)

  3. Procedure Duration [ Time Frame: During the procedure ]
    In minutes from the insertion of the sheath to its exertion.

  4. Radiation Duration [ Time Frame: During the procedure ]
    Which is measured by the radiological device in minutes.

  5. Radiology Dose [ Time Frame: During the procedure ]
    Which is measured by the radiological device in mGy.

  6. Compression "hemostasis" time [ Time Frame: Up to 240 minutes after band placement ]
    The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes.

  7. Arterial spasm [ Time Frame: During the procedure ]

    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.


  8. Hematoma and bleeding complications [ Time Frame: Within 24 hours after the procedure ]
    It is defined by EASY hematoma scale.

  9. Ischemic changes to the hand [ Time Frame: Within 24 hours after the procedure ]
    It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.

  10. Crossover (failure to puncture) [ Time Frame: During the procedure ]
    It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access

  11. Procedural pain [ Time Frame: During the procedure ]
    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.

  12. Post-procedural pain [ Time Frame: Within 24 hours after the procedure ]
    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.

  13. Rare complications [ Time Frame: Within 24 hours after the procedure ]
    Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.

  14. Radial Artery Occlusion on follow up [ Time Frame: After 2 weeks of the procedure. ]
    Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who agrees to participate in the study and signs the consent form.
  • Patients with indication of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125992


Contacts
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Contact: Yunis Daralammouri, asst. prof. +972598434614 yunis71@yahoo.de
Contact: Yahya S Mosleh, MD +972599671495 mosleh.yahya@gmail.com

Locations
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Palestinian Territory, occupied
An-Najah National University Hospital Recruiting
Nablus, Palestinian Territory, occupied
Contact: Yunis Daralammmouri, asst. prof.    +972598434614    yunis71@yahoo.de   
Contact: Yahya S Mosleh, MD    +972599671495    mosleh.yahya@gmail.com   
Sponsors and Collaborators
An-Najah National University
Investigators
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Principal Investigator: Yunis Daralammouri, asst. prof. An-Najah National University

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Responsible Party: Yunis Daralammouri, Assistant Professor, An-Najah National University
ClinicalTrials.gov Identifier: NCT04125992     History of Changes
Other Study ID Numbers: DRAvsFRA1
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yunis Daralammouri, An-Najah National University:
cardiac catheterization
coronary angiography
coronary angioplasty
snuff-box
snuffbox
snuff box
radial fossa
distal radial artery
radial artery
safeguard
distal radial access
distal radial angiography
radial access
angiography
distal radial
radial
coronary arteries
randomized controlled trial
left distal radial artery
Percutaneous Coronary Intervention
radial artery occlusion
forearm radial access
forearm radial artery
coronary catheterization
catheterization
left distal radial
angioplasty
coronary artery disease
radial vs distal
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Atherosclerosis
Acute Coronary Syndrome
Angina Pectoris
ST Elevation Myocardial Infarction
Angina, Unstable
Angina, Stable
Infarction
Chest Pain
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms