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

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison (3-DCA)

29. oktober 2007 opdateret af: Antwerp Cardiovascular Institute Middelheim

Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"

Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease.

Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Antwerp, Belgien, 2020
        • Antwerp Cardiovascular Institute Middelheim

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Clinical

  • Age > 18 years.
  • Ability to give informed consent.

  • Clinical evidence of coronary artery disease:

    • recent (< 72 hours) acute myocardial infarction,
    • stable angina with documented positive stress test,
    • unstable angina with documented ischemia (positive ECG or troponin test or documented positive stress test).

Angiographic

  • Eligibility for PCI in at least one de-novo stenosis in a native coronary artery, after the index angiogram.
  • Planned PCI according to a previous coronary angiogram.

Exclusion Criteria:

Clinical

  • Pregnancy.
  • Chronic or acute renal failure (serum creatinine > 1.8 mg/dL or hemodialysis).
  • Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
  • Contraindications or known hypersensitivity to contrast media.
  • Enrollment in another study protocol.

Angiographic

  • Significant left main coronary artery disease.
  • PCI for a total occlusion of a major coronary vessel (LAD, LCX or RCA).
  • Extensive thrombotic burden in a coronary lesion (thrombus grade 3/4).
  • TIMI flow <3 distal to the lesion.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 1
Paired comparison of 2 angiographic techniques
Procedure: 3-dimensional coronary angiography
3-dimensional coronary angiography
Andre navne:
  • koronar angiografi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
standard coronary angiography over/underestimates the length of the coronary segment evaluated.
Tidsramme: peri-procedural
peri-procedural

Sekundære resultatmål

Resultatmål
The length of the segments, evaluated with standard and 3-D angiography, will be compared with the length of the segment measured with the marker guide-wire.
Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
All the QCA results of standard angiography will be compared with those of 3-D angiography, in particular in the segments where the lesion is.
The percentage of vessel foreshortening of the standard angiography operator-selected "working view" will be compared to the least foreshortened view automatically selected with the 3-D angiography reconstruction.

Samarbejdspartnere og efterforskere

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

Sponsor

Antwerp Cardiovascular Institute Middelheim

Efterforskere

  • Ledende efterforsker: Pierfrancesco Agostoni, MD, Antwerp Cardiovascular Institute Middelheim
  • Studiestol: Stefan Verheye, MD, PhD, Antwerp Cardiovascular Institute Middelheim
  • Studieleder: Glenn Van Langenhove, MD, PhD, Antwerp Cardiovascular Institute Middelheim

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. oktober 2006

Studieafslutning (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først indsendt

13. marts 2007

Først indsendt, der opfyldte QC-kriterier

13. marts 2007

Først opslået (Skøn)

14. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2007

Sidst verificeret

1. oktober 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACIM 2006-001

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 .

Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med 3-dimensional coronary angiography

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner