- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07686003
Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries (FLOW-PRADA)
Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries: The FLOW-PRADA Study
Transradial access (TRA) has been widely adopted for coronary angiography and percutaneous coronary intervention, as it has been shown to significantly reduce bleeding complications, vascular complications, and mortality compared with transfemoral access (TFA). Based on this evidence, recent international guidelines recommend TRA as the preferred access strategy.
Radial artery occlusion (RAO), a potential complication following TRA, is often clinically silent and therefore underestimated. However, RAO has important clinical implications, particularly in patients who may require repeated coronary procedures, those in whom the radial artery may be used as a conduit for coronary artery bypass grafting, or patients with chronic kidney disease requiring arteriovenous fistula formation. Therefore, maintaining radial artery patency after the procedure is of considerable clinical importance.
Distal radial access (DRA), which utilizes the radial artery at the anatomical snuffbox, is a relatively recent approach. Multiple studies and meta-analyses have demonstrated that DRA provides comparable procedural success rates to TRA while significantly reducing bleeding complications and the incidence of RAO. Notably, despite the generally accepted association between smaller vessel diameter and higher risk of occlusion, DRA paradoxically shows a lower incidence of RAO. The underlying mechanism for this observation remains incompletely understood.
Sgueglia et al. evaluated peak systolic velocity using Doppler ultrasonography under conditions of arterial compression and reported that antegrade blood flow was better preserved during distal radial artery compression compared with proximal radial artery compression. This finding suggests a potential mechanistic explanation for the lower incidence of RAO observed with DRA.
However, there is a paucity of studies that systematically evaluate hemodynamic changes under simulated real-world hemostatic conditions at both proximal and distal radial arteries.
Therefore, the aim of this study is to quantitatively assess hemodynamic changes induced by simulated occlusive hemostasis at the proximal and distal radial arteries using Doppler ultrasonography, and to elucidate the mechanisms underlying the lower incidence of RAO observed with DRA.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jun-Won Lee, MD, PhD
- E-mail: ljwcardio@yonsei.ac.kr
Undersøgelse Kontakt Backup
- Navn: Jung-Woo Son
- Telefonnummer: +82-33-741-0910
- E-mail: soneycar@gmail.com
Studiesteder
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, Sydkorea, 26426
- WonJu Severance Christian Hospital
-
Kontakt:
- Jung-Woo Son, MD
- Telefonnummer: +82-33-741-0920
- E-mail: soneycar@gmail.com
-
Kontakt:
- Jun-Won Lee, MD, PhD
- Telefonnummer: +82-33-741-0920
- E-mail: ljwcardio@yonsei.ac.kr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
A. Adults aged ≥19 years B. Patients scheduled for coronary angiography due to atypical chest pain, stable angina, or acute coronary syndrome C. Patients undergoing transthoracic echocardiography for assessment of cardiac function prior to coronary angiography D. Palpable proximal and distal radial arteries
Exclusion Criteria:
A. Cardiogenic shock B. Patients who have undergone coronary angiography via distal radial access prior to echocardiographic evaluation C. Refusal or inability to provide informed consent D. Presence of an ipsilateral arteriovenous fistula E. Pregnant or breastfeeding women
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patent hemostasis of distal radial artery
Patent hemostasis of distal radial artery using TR band
|
Simulated patent hemostasis using air-filled TR band
|
|
Patent hemostasis of proximal radial artery
Patent hemostasis of proximal radial artery using TR band
|
Simulated patent hemostasis using air-filled TR band
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in end-diastolic velocity
Tidsramme: Periprocedural
|
Difference in end-diastolic velocity between proximal and distal radial arteries during patent hemostasis by Doppler ultrasound
|
Periprocedural
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Flow preservation ratio
Tidsramme: Periprocedural
|
Flow preservation ratio in proximal and distal radial arteries
|
Periprocedural
|
|
Blood flow volume
Tidsramme: Periprocedural
|
Blood flow volume in proximal and distal radial arteries
|
Periprocedural
|
|
Flow volume per beat
Tidsramme: Periprocedural
|
Flow volume per beat in proximal and distal radial arteries
|
Periprocedural
|
|
Pulsatility index
Tidsramme: Periprocedural
|
Pulsatility index in proximal and distal radial arteries
|
Periprocedural
|
|
Resistance index
Tidsramme: Periprocedural
|
Resistance index in proximal and distal radial arteries
|
Periprocedural
|
|
Peak systolic velocity
Tidsramme: Periprocedural
|
Peak systolic velocity in proximal and distal radial arteries
|
Periprocedural
|
|
Velocity time integral
Tidsramme: Periprocedural
|
Velocity time integral in proximal and distal radial arteries
|
Periprocedural
|
|
Radial artery occlusion
Tidsramme: up to 1 month
|
Radial artery occlusion
|
up to 1 month
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jung-Woo Son, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CR326050
Plan for individuelle deltagerdata (IPD)
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