- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00424450
Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound
Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)
연구 개요
상세 설명
Contrast ultrasound perfusion imaging (CUPI) was developed at the University Hospital of Freiburg, Germany in 2005 for the assessment of skeletal muscle perfusion deficits in peripheral arterial disease (PAD). It has been reported previously by the investigators that the contrast agent wash-in is significantly prolonged in PAD with respect to the extent of disease and with respect to the degree of collateralization.
The goal of this study is to examine the effect of revascularization procedures on muscular perfusion in 15 PAD patients undergoing lower limb artery bypass surgery and 15 PAD patients undergoing percutaneous angioplasty (PTA) before and after intervention. Based on the data from a pilot study, a power calculation for an alpha = 5% with a power of 80% and an assumed standard deviation of 10 s yielded a necessary patient number of 29 per group to detect a decrease in wash-in time of 7.5 s. In this intra-individual comparison we aim to compare 30 patients pre with the same 30 patients post revascularization.
We hypothesize 1) that the contrast agent wash-in in the target muscle will significantly improve after revascularization and 2) that standard non-invasive tests such ankle-brachial index (ABI) will not correlate with the CUPI findings. The results of this trial will help to further understand the diagnostic accuracy of CUPI in quantifying limb muscle perfusion deficits.
Patients with symptomatic PAD and an indication for revascularization will undergo CUPI less than 8 weeks prior and less than 3 weeks after the revascularization procedure. A second follow-up CUPI examination is performed 3 - 6 months after the revascularization procedure.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Freiburg, 독일, 79106
- University Hospital of Freiburg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- male or females > 18 years old
- PAD Fontaine stages IIb, III or IV
- conventional angiography or magnetic resonance angiography
- a severe lesion (≥80% stenosis with a peak velocity ratio intrastenotic / prestenotic ≥4.0 in Duplex ultrasound or occlusion) has to be present in the common or external iliac, common or superficial femoral, popliteal or one or more infrapopliteal arteries, which is accessible to revascularization
- indication for revascularization, i.e. lower limb artery bypass surgery or PTA (based on the treating physician's decision)
- revascularization appointed within the next 6 weeks of study inclusion
- patients, who have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for the required follow-up
Exclusion Criteria:
- failed or incomplete revascularization
- patients with chronic heart failure NYHA IV
- patients with acute coronary syndrome
- patients with severe pulmonary hypertension
- patients who are assigned to conservative PAD treatment (according to the treating physician's decision)
- refusal or inability to give informed consent
- patients who are enrolled into another clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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PAD patients
30 PAD patients
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bypass of severe atherosclerotic vascular lesion
다른 이름들:
PTA of severe atherosclerotic lesion
다른 이름들:
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공동 작업자 및 조사자
수사관
- 연구 의자: Christoph Hehrlein, MD, Department of Cardiology and Angiology, University Hospital of Freiburg, Germany
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
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. .
말초 동맥 질환에 대한 임상 시험
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C. R. Bard완전한
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Mayo Clinic초대로 등록
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University Hospital, Strasbourg, France완전한