Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries (FLOW-PRADA)

1. juli 2026 opdateret af: Jung-Woo Son, Wonju Severance Christian Hospital

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

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

220

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Gangwon-do
      • Wŏnju, Gangwon-do, Sydkorea, 26426
        • WonJu Severance Christian Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults (≥19 years) scheduled for coronary angiography for atypical chest pain, stable angina, or acute coronary syndrome, undergoing pre-procedural transthoracic echocardiography, with palpable proximal and distal radial arteries; excluding those with cardiogenic shock, prior distal radial coronary angiography before echocardiography, inability/refusal to consent, ipsilateral arteriovenous fistula, or pregnancy/breastfeeding.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Jung-Woo Son, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CR326050

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

3
Abonner