The Primary Endpoint is to Compare the Incidence of Forearm RAO Between Distal and Traditional Radial Access Assessed by Vascular Ultrasound At Discharge

NCT06688747 | Not Yet Recruiting

• 1 other identifier: AssiutU/Mostafa Talaat
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention

Conditions

Coronary Angiography and Intervention

Keywords

RAO, DISTAL, Traditional radial

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge

  The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure and follow up after 3 months

  One year

Study Arms (2)

Distal access

Distal radial access for coronary angiography and intervention

Traditional access

Distal radial access for coronary angiography and intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients will undergo coronary angiography and\\or PCI in Assiut university heart hospital

You may qualify if:

• Aged ≥18 y
• Signed informed consent form
• Indication to diagnostic coronary angiography or PCI
• Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath

You may not qualify if:

• Chronic hemodialysis
• Treatment of a coronary chronic total occlusion (CTO) lesion
• Patients who underwent CA or PCI with radial access before

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Sgueglia GA, Santoliquido A, Gaspardone A, Di Giorgio A. First Results of the Distal Radial Access Doppler Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1281-1283. doi: 10.1016/j.jcmg.2020.11.023. Epub 2021 Jan 13. No abstract available.

  PMID: 33454250 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mostafa Talaat Bakr Mostafa Mostafa Talaat, MD

CONTACT

0201007952006; Mostafatalaat554@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology specialist

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11