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The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

18. august 2014 opdateret af: Xuzhou Central Hospital

In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis.

The improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement's accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.

This study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Jiangsu
      • Xuzhou, Jiangsu, Kina, 221000
        • Rekruttering
        • Xuzhou Central Hospital

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 20-80, All genders
  2. Unlimited time of implantation of coronary artery stents
  3. Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
  4. No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
  5. Routine re-testing 9-12 months after stent implantation.

Exclusion Criteria:

  1. Renal insufficiency (serum creatinine > 120 umol/L)
  2. Allergy of contrast
  3. Severe heart failure
  4. Uncontrollable heart rate or contraindication of taking metoprolol
  5. Unstable condition
  6. the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gemstone CT
Gemstone CT :Discovery CT750 HD(high definition) ,GE(General Electric Co.) Healthcare, Milwaukee; CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient
Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.
Andre navne:
  • OKT
  • Gemstone CT
  • 320-detector row spiral CT
Aktiv komparator: 320-detector row spiral CT
320-detector row spiral CT:Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .
Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.
Andre navne:
  • OKT
  • Gemstone CT
  • 320-detector row spiral CT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
Tidsramme: On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins
Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.
On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
Tidsramme: one month
In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients
one month

Andre resultatmål

Resultatmål
Tidsramme
Measurement of the physical characteristics of in-stent restenosis structures seen on OCT
Tidsramme: On the day in which a patient receives the check of OCT
On the day in which a patient receives the check of OCT

Samarbejdspartnere og efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juni 2014

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

10. august 2014

Først indsendt, der opfyldte QC-kriterier

18. august 2014

Først opslået (Skøn)

19. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2014

Sidst verificeret

1. august 2014

Mere information

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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