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

Not Applicable

• Conditions: Patients Undergoing Diagnostic Coronary Angiography
• Interventions: Other: Traditional punkcture site and No anticoagulation; Other: Traditional punkcture site and ACT-guided anticoagulation

• Registration Number: NCT04301921
• Lead Sponsor: Prof. Dr. med. Ingo Eitel

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24
• Study Start: 2020-05-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Traditional punkcture site and No anticoagulation	Traditional puncture site + no anticoagulation
Group 2	Traditional punkcture site and ACT-guided anticoagulation	Traditional puncture site + ACT-guided anticoagulation

Primary Outcome Measures

Name	Time	Method
Bleeding events	Day 1	Will be bleeding events according to Bleeding Academic Research Consortium (BARC) criteria.
Occurrence of postprocedural RAO	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.

Secondary Outcome Measures

Name	Time	Method
Sonographic characteristics of radial artery occlusion	3 Month	Occlusion lengths or minimal residual perfusion