Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio

Patients Undergoing Diagnostic Coronary Angiography Clinical Trial

— RAPID-1  

Official title:

Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Diagnostic Transradial Coronary Angiography Without Systemic Anticoagulatio

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301921
• Other study ID #: RAPID-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2020
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Diagnostic Coronary Angiography

Intervention

Other:
• Traditional punkcture site and No anticoagulation
Traditional punkcture site and No anticoagulation
• Traditional punkcture site and ACT-guided anticoagulation
Traditional punkcture site and ACT-guided anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. med. Ingo Eitel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of postprocedural RAO	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
Primary	Bleeding events	Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.	Day 1
Secondary	Sonographic characteristics of radial artery occlusion	Occlusion lengths or minimal residual perfusion	3 Month