Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access

Launched by ASSOCIAZIONE PER LO STUDIO DELLE MALATTIE CARDIOVASCOLARI CARDIVA ONLUS · Feb 14, 2025

Keywords

ClinConnect Summary

The ALPHA&OMEGA trial is a research study that aims to improve how doctors access blood vessels in the wrist for heart procedures, specifically looking at a method called distal radial access (DRA). This trial will compare DRA using advanced techniques, like ultrasound-guided puncture and enhanced ways to stop bleeding after the procedure, to traditional methods. The goal is to see if these new approaches can make the DRA method more successful and help patients recover faster.

To be eligible for this study, participants need to be at least 18 years old and have certain heart conditions that require a procedure called coronary angiography or PCI (a type of heart surgery). They should also be able to give written consent and have a good blood flow in their wrists. If someone is experiencing a heart attack or has other serious health issues, they won't be able to participate. Those who join the study can expect to undergo the heart procedure with different access methods while being closely monitored by healthcare professionals throughout the process. This trial is important because it will help determine the safest and most effective ways to perform these procedures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• • Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
• • Patients planned for coronary angiography or PCI.
• • Patients able to provide written informed consent.
• • Patient is willing to comply with all study protocol required evaluations.
• • Palpable radial pulse both at conventional and distal puncture site.
• • Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization.
• Exclusion Criteria:
• • Acute ST-segment elevation myocardial infarction.
• • Cardiogenic shock.
• • Chronic hemodialysis.
• • Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
• • Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
• • Patients unable to provide written informed consent.