- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831322
A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention
February 14, 2023 updated by: The First Hospital of Qinhuangdao
Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio.
Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists.
Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access.
Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by flow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
600
Phase
- Not Applicable
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
-
-
Hebei
-
Qinhuangdao, Hebei, China, 066000
- Qingsheng wang
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- admitted for transradial catheterization.
Exclusion Criteria:
- femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure
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
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radial artery occlusion
Radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination.
|
Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease
|
Other: radial artery normal
Radial artery normal was blood flow signal by Doppler ultrasound
|
Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
radial artery occlusion
Time Frame: 6 month
|
radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 10, 2016
Primary Completion (Actual)
September 5, 2016
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
July 4, 2016
First Submitted That Met QC Criteria
July 12, 2016
First Posted (Estimate)
July 13, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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