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Invasive Measurement of Axial Plaque Stress, the Pilot Study (REASSURE)

9. marts 2015 opdateret af: Bon-Kwon Koo, Seoul National University Hospital

Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data

In this study, the investigators sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, the investigators will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Although current risk assessment for plaque rupture have mainly focused on evaluation of plaque vulnerability. However, according to the general mechanism of material failure, plaque rupture occurs whenever the external hemodynamic stress exceeds the durability of the plaque.

Recently, we evaluated the axial plaque stress, which is axial component of total traction acting on the plaque, and showed that the axial plaque stress possess significantly higher magnitude than previously known wall shear stress.

However, the axial plaque stress in our previous research was measured with computational flow dynamics analysis using coronary artery model from coronary CT angiography.

In this study, we sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, we will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Daegu, Korea, Republikken
        • Keimyung University Dongsan Medical Center
      • Goyang, Korea, Republikken
        • Inje University Ilsan Paik Hospital
      • Seoul, Korea, Republikken
        • Seoul National University Hospital
      • Ulsan, Korea, Republikken
        • Ulsan University Hospital, University of Ulsan College of Medicine

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with angina pectoris

Beskrivelse

Inclusion Criteria:

  • 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
  • 2. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries.
  • 3. Pressure wire pullback tracing and Optical Coherence Tomography ware successfully performed

Exclusion Criteria:

  • 1. Stenosis at distal coronary or small vessel.
  • 2. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
  • 3. Inadequate quality of Optical Coherence Tomography
  • 4. No data of Fractional Flow Reserve or Pressure wire pullback tracing or inadequate data of Fractional Flow Reserve or Pressure wire pullback tracing

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
OCT and Pressure wire pullback tracing
This study is pilot study evaluating the feasibility of invasive measurement and estimation of hemodynamic stress acting on plaque as well as co-registration of hemodynamic data with plaque geometric data, which is obtained by optical coherence tomography
Procedure: Device
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
Andre navne:
  • Optisk kohærenstomografi
Procedure: Device
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Andre navne:
  • Fractional flow reserve measurement with pressure pullback tracing

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Axial plaque stress (Axial component of total traction acting on the plaque)
Tidsramme: up to 1 week
up to 1 week
Cap thickness (measured from optical coherent tomography)
Tidsramme: up to 1 week
Cap thickness measured from optical coherent tomography
up to 1 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wall shear stress (Friction vector on the surface of the plaque)
Tidsramme: up to 1 week
Friction vector on the surface of the plaque
up to 1 week
Proportion of thin cap fibrous atheroma
Tidsramme: up to 1 week
Plaques with cap thickness < 60um
up to 1 week
Cardiac death and all-cause mortality
Tidsramme: 1 year
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
1 year
Non-fatal target vessel myocardial infarction
Tidsramme: 1 year
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
1 year
Target vessel restenosis
Tidsramme: 1 year
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Seoul National University 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

1. marts 2015

Primær færdiggørelse (Forventet)

1. marts 2017

Studieafslutning (Forventet)

1. marts 2018

Datoer for studieregistrering

Først indsendt

4. marts 2015

Først indsendt, der opfyldte QC-kriterier

9. marts 2015

Først opslået (Skøn)

17. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCT723631

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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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