- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317533
Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access
December 18, 2023 updated by: Wujin People's Hospital
Prevalence of Distal Radial Artery Occlusion (DRAO) in Patients Undergoing Cardiovascular Catheterization Via Distal Radial Access (DRA)
Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion.
However, the distal radial artery occlusion has not been detected.
This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound.
In addition, the risk factors of distal radial artery occlusion are also analyzed.
Study Type
Observational
Enrollment (Actual)
805
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Changzhou, Jiangsu, China, 213017
- Changzhou Wujin People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Palpable distal radial artery
Exclusion Criteria:
- Age ≥ 90years;
- Height≥ 185cm;
- Cardiogenic shock;
- Refuse to sign the written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of distal radial artery occlusion
Time Frame: 3 months after procedure
|
Prevalence of the distal radial artery occlusion is detected using ultrasound
|
3 months after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of distal radial artery occlusion
Time Frame: 1 day after procedure
|
Prevalence of the distal radial artery occlusion is detected using ultrasound
|
1 day after procedure
|
|
Thickness of distal radial artery
Time Frame: 3 months after procedure
|
Comparison of the thickness of distal radial artery intima using ultrasound
|
3 months after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gaojun Cai, MD, Cardiovascular department, Changzhou Wujin People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li F, Shi GW, Yu XL, Song RX, Xiao JQ, Huang HM, Li LM, Zhang LY, Gong C, Cai GJ. Safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial artery access in the anatomical snuffbox: a single-centre prospective cohort study using a propensity score method. BMC Cardiovasc Disord. 2022 Mar 2;22(1):74. doi: 10.1186/s12872-022-02518-8.
- Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.
- Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
- Sattar Y, Talib U, Faisaluddin M, Song D, Lak HM, Laghari A, Khan MZ, Ullah W, Elgendy IY, Balla S, Daggubati R, Kawsara A, Jneid H, Alraies CM, Alam M. Meta-Analysis Comparing Distal Radial Versus Traditional Radial Percutaneous Coronary Intervention or Angiography. Am J Cardiol. 2022 May 1;170:31-39. doi: 10.1016/j.amjcard.2022.01.019. Epub 2022 Mar 2.
- Prasad RM, Pandrangi P, Pandrangi G, Yoo H, Salazar AM, Ukponmwan E, Kehdi M, Abela G. Meta-Analysis Comparing Distal Radial Artery Approach Versus Traditional for Coronary Procedures. Am J Cardiol. 2022 Feb 1;164:52-56. doi: 10.1016/j.amjcard.2021.10.034. Epub 2021 Nov 20.
- Pacchioni A, Mugnolo A, Sanz Sanchez J, Sgueglia GA, Pesarini G, Bellamoli M, Sacca S, Ribichini F, Reimers B, Gasparini GL. Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients. Catheter Cardiovasc Interv. 2022 Feb;99(3):827-835. doi: 10.1002/ccd.30005. Epub 2021 Nov 16.
- Aminian A, Sgueglia GA, Wiemer M, Gasparini GL, Kefer J, Ruzsa Z, van Leeuwen MAH, Vandeloo B, Ungureanu C, Kedev S, Iglesias JF, Leibundgut G, Ratib K, Bernat I, Barriocanal I, Borovicanin V, Saito S. Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study. Am Heart J. 2022 Feb;244:19-30. doi: 10.1016/j.ahj.2021.10.180. Epub 2021 Oct 16.
- Shi G, Li F, Zhang L, Gong C, Xue S, Song Y, Cai G. Retrograde Recanalization of Occluded Radial Artery: A Single-Centre Experience and Literature Review. J Endovasc Ther. 2022 Oct;29(5):755-762. doi: 10.1177/15266028211067732. Epub 2022 Jan 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
December 18, 2023
Study Completion (Actual)
December 18, 2023
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
April 6, 2022
First Posted (Actual)
April 8, 2022
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLH20220312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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