- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00447148
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison (3-DCA)
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
-
Antwerp, Belgia, 2020
- Antwerp Cardiovascular Institute Middelheim
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 1
Paired comparison of 2 angiographic techniques
|
3-dimensional coronary angiography
Andre navn:
|
Hva måler studien?
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.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: 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
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACIM 2006-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Koronararteriesykdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aortic origin of the coronary artery (AAOCA)Italia
-
Medtronic CardiovascularFullførtArteriosclerosis of coronary artery bypass graftCanada, Forente stater
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
William Beaumont HospitalsFullførtKoronararteriesykdom | Arteriosclerosis of coronary artery bypass graftForente stater
-
Izmir Bakircay UniversityFullførtMyocardial Bridge of Coronary ArteryTyrkia
-
ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiFullførtMyocardial Bridge of Coronary ArteryItalia
-
University Hospital OstravaRekrutteringIn-Stent Carotis Artery RestenosisTsjekkia
-
Sohag UniversityHar ikke rekruttert ennåUmblical artery Doppler under termin graviditetEgypt
-
Baylor College of MedicineFullførtLungeblødning | MAPCA - Major Aortopulmonary Collateral ArteryForente stater
Kliniske studier på 3-dimensional coronary angiography
-
Jordan Collaborating Cardiology GroupFullført
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RekrutteringMitral oppstøt | Kirurgi | Hjerteklaffsykdom | Mitralklaffsykdom | Mitralklaffkirurgi | Mitralventil reparasjonNederland
-
Hemolens Diagnostics Sp. z o.o.GENELYTICA Sp. z o.o.RekrutteringKoronararteriesykdom | Stabil iskemisk hjertesykdomPolen