- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01205425
Computed Tomography Coronary Angiography Before Stent Implantation
Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:
Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Warsaw, Polen, 04-628
- Institute of Cardiology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Stable coronary artery disease
- Planned stent implantation into single lesion in native coronary artery
- Planned stent diameter: 2.5-4.0 mm
Exclusion Criteria:
- Women younger than 50 years
- Lesion location in left main coronary artery
- Atrial fibrilation or other significant arrythmia
- Severe chronic obturatory pulmonary disease
- Hyperthyroidism
- Known allergy to contrast media
- Glomerular filtration rate < 30
- Treatment of bifurcation lesion
- Stent implantation for in-stent restenosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CT
Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.
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The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI.
Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)
|
|
Aktiv komparator: Angio
Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.
|
Interventional cardiologist will be blinded to the images obtained by CT.
The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Minimal in stent lumen area as assessed by IVUS
Tidsramme: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
Tidsramme: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mean stent lumen area
Tidsramme: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
|
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Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
Tidsramme: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
Tidsramme: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jerzy Pregowski, MD, Institute of Cardiology, Warsaw, Poland
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N N403 295736
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