Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio (RAPID-1)
April 22, 2020 updated by: Prof. Dr. med. Ingo Eitel
To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion
Study Overview
Status
Unknown
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical indication to perform diagnostic coronary angiography
- Age > 18 years
- Written informed consent
Exclusion Criteria:
- Preexisting or already administered anticoagulation prior to coronary angiography
- Planned coronary intervention
- Preexisting radial artery occlusion or missing pulse at the potential puncture sites
- Allergy / intolerance to anticoagulants
- Active bleeding or comorbidity with elevated bleeding risk
- Pregnancy
- Inability to sign informed consent
- Participation in another trial
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group 1
Traditional puncture site + no anticoagulation
|
Traditional punkcture site and No anticoagulation
|
|
Other: Group 2
Traditional puncture site + ACT-guided anticoagulation
|
Traditional punkcture site and ACT-guided anticoagulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of postprocedural RAO
Time Frame: Day 1
|
Will be the occurrence of postprocedural RAO assessed with high-resolution vascular ultrasound.
Experienced sonographers will perform color Doppler ultrasound in all study patients after removal of the compression device to examine the radial, ulnar, and brachial arteries of the access forearm.
|
Day 1
|
|
Bleeding events
Time Frame: Day 1
|
Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sonographic characteristics of radial artery occlusion
Time Frame: 3 Month
|
Occlusion lengths or minimal residual perfusion
|
3 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
September 30, 2021
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RAPID-1
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.