- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01205425
Computed Tomography Coronary Angiography Before Stent Implantation
Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Warsaw, 폴란드, 04-628
- Institute of Cardiology
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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)
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활성 비교기: Angio
Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Minimal in stent lumen area as assessed by IVUS
기간: 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.
기간: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Mean stent lumen area
기간: 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.
기간: 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)
기간: Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jerzy Pregowski, MD, Institute of Cardiology, Warsaw, Poland
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .