새로운 영상 기술을 활용한 말초동맥질환 환자의 증상적 및 전신적 죽상동맥경화반 활동 (SISYPHUS)
새로운 영상 기법을 사용한 말초동맥질환 환자의 증상성 및 전신성 죽상동맥경화반 활동
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
In peripheral arterial disease (PAD), arteries in the lower body can become narrowed and develop blockages due to a process called atherosclerosis, leading to reduced blood flow to the lower limbs. Symptoms can range from mild cramping pain in legs on walking, to loss of parts of the leg. Patients with PAD are also at a high risk of blockages in other arteries in the body that can lead to problems such as heart attacks and strokes. Despite improvements in medical treatments and surgery, the outlook for patients with PAD has not improved.
Further information is required to understand the relationships between the processes that lead to narrowing and blockages (atherosclerosis) of the arteries and if they behave the same in different parts of the body. This can help to identify targeted treatments to reduce the risk of the disease getting worse and avoid heart attacks and strokes.
In this study investigators plan to recruit 100 people with symptomatic PAD to undergo a series of whole body PET-CT and CT angiogram scans using different tracers targeting the processes involved in atherosclerosis. Investigators will aim to co-enrol patients taking part in the LEADER-PAD study (NCT04774159).
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Allison c Winarski, MBChB, MRCS(Ed)
- 전화번호: +447495905258
- 이메일: awinarsk@ed.ac.uk
연구 연락처 백업
- 이름: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- 전화번호: +44 01312423585
- 이메일: rachael.forsythe@ed.ac.uk
연구 장소
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Midlothian
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Edinburgh, Midlothian, 영국, EH16 4SA
- 모병
- Royal Infirmary of Edinburgh
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연락하다:
- Allison C Winarski, MBChB MRSC(Ed)
- 전화번호: +447495905258
- 이메일: awinarsk@ed.ac.uk
-
연락하다:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
- 전화번호: 01312423585
- 이메일: rachael.forsythe@ed.ac.uk
-
부수사관:
- Allison C Winarski, MBChB MRCS (Ed)
-
수석 연구원:
- Rachael O Forsythe, MBChB, PhD, FRCS (Vascular)
-
부수사관:
- David E Newby, BSc (Hons)PhD BM DM DSc FRCP
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.
설명
Inclusion Criteria:
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Male or female aged > 18 years
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Symptomatic atherosclerotic peripheral artery disease;
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Intermittent claudication; with ankle/arm blood pressure ratio <0.90 or artery stenosis >50% in addition to at least one of the following;
- >1 vascular bed affected by atherosclerosis
- Diabetes
- Heart failure
- Chronic kidney disease (eGFR < 60 mL/min/1.73 m2)
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Rest pain or necrosis of limb or gangrene of limb
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Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery
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Leg or foot amputation for arterial vascular indications
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Ability to give written or verbal informed consent
Exclusion Criteria:
- Contraindication to colchicine or iodinated contrast
- Long term requirement for colchicine for another clinical indication
- Active diarrhoea
- Recent lower limb revascularisation for symptomatic disease (<6 weeks)
- Renal failure (glomerular filtration rate <30 mL/min/1.73 m2)
- Cirrhosis or severe chronic liver disease
- Women who are pregnant or breast-feeding
- Women of child-bearing potential not protected by reliable contraception or is planning conception during the study
- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (apart from azithromycin)
- Patients deemed unlikely to return for follow up
- Life expectancy <1 year
- Inability or unwilling to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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증상이 있는 말초동맥질환 환자
|
Targeting vascular inflammation Targeting thrombus activity Targeting vascular microcalcification To determine anatomical and morphological atherosclerotic plaque characteristics |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
기간: From baseline imaging until completion imaging at 1 year
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The 3 primary endpoints will be the location and degree of:
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From baseline imaging until completion imaging at 1 year
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories
기간: From baseline imaging until completion imaging at 1 year
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The secondary outcome measures will be the location and degree of inflammation, calcification and thrombus activity in remote arterial territories, including the coronary arteries, cerebral arteries, aorta and mesenteric vessels, as determined by SUVs of [68Ga]DOTATATE, [18F]NaF and [18F]GP1, respectively. |
From baseline imaging until completion imaging at 1 year
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CT plaque morphology
기간: From baseline imaging to completion imaging at 1 year
|
Investigators will characterise CT plaque morphology (total, calcified, non-calcified and low-attenuation plaque) in peripheral and systemic arterial beds and compare this to areas of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF uptake. |
From baseline imaging to completion imaging at 1 year
|
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The association between patient risk factors for cardiovascular disease and PET tracer uptake
기간: Frome baseline imaging to completion imaging at 1 year
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Investigators will explore the association between patient risk factors for cardiovascular disease (hypertension, diabetes, smoking) and the degree of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF uptake as quantified by standard uptake values (SUVs). This will be measured by odds ratio (OR) with 95% confidence interval (CI) for each risk factor-tracer combination. |
Frome baseline imaging to completion imaging at 1 year
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The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.
기간: From baseline imaging to completion imaging at 1 year
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Investigators will also aim to characterise the relationship between microcalcification progressing to calcification and the uptake of [18F]NaF. This will be assessed using baseline and follow-up [18F]NaF PET-CT SUVs and their correlation with calcified regions on CT angiography. |
From baseline imaging to completion imaging at 1 year
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
기간: From baseline imaging to completion imaging at 1 year
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Exploratory endpoints will include major adverse cardiovascular events (acute myocardial infarction, stroke or cardiovascular death) and major adverse limb events (revascularisation or lower limb amputation) as well as death from any cause. |
From baseline imaging to completion imaging at 1 year
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Rachael O Forsythe, MBChB, PhD, FRCS (Vascular), University of Edinburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- AC25008
- BHF PG/24/12097 (기타 보조금/기금 번호: British Heart Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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