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Automated ABPI in Peripheral Arterial Disease a Pilot Study (AUTO-PAD)

2026년 9월 30일 업데이트: Hull University Teaching Hospitals NHS Trust

Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study

The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 영국
      • Hull, 영국, HU3 2JZ
        • 모병
        • Hull University Teaching Hospitals NHS Trust
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Group 1: Asymptomatic PAD:

Patients identified by the GP (PIC sites). Records screened to identify 'at risk' of PAD with >1 cardiovascular disease risk factor

Group 2: Suspected symptomatic PAD:

2a. Patients with suspected IC referred to dedicated nurse-led claudication clinic.

Group 2b. Patients with suspected CLTI referred to dedicated urgent vascular (HOT) clinic.

Group 3: Patients undergoing surveillance seen in dedicated clinics by vascular scientists

설명

Inclusion Criteria:

Group 1: Asymptomatic

  • Adults aged 18 and over
  • At risk of PAD with ≥1 cardiovascular risk factor
  • No previous diagnosis of PAD
  • English speaking and able to understand test protocols

Group 2a: Suspected PAD (intermittent claudication)

  • Adults aged 18 and over
  • Referred and booked into the nurse-led claudication clinic due to signs/symptoms in keeping with suspected intermittent claudication
  • English speaking and able to understand test protocols

Group 2b: Suspected PAD (CLTI)

  • Adults aged 18 and over
  • Referred and booked into the vascular HOT clinic due to signs/symptoms in keeping with suspected CLTI
  • English speaking and able to understand test protocols

Group 3: Post-bypass surveillance

  • Adults aged 18 and over
  • History of lower limb bypass surgery, enrolled in and attending the local surveillance programme
  • English speaking and able to understand test protocols

Exclusion Criteria:

  • Patients who are unable to provide informed consent
  • Recent (≤4 weeks) lower-limb surgery
  • Ulcers, casts or bandages that cannot or should not be compressed
  • Patients who have had a therapeutic intervention (stent or graft) which extends to the ankle
  • Patients with known or suspected acute deep vein thrombosis (DVT) or superficial thrombophlebitis
  • Marked oedema in one or both feet
  • Inability to tolerate a supine position
  • Patients with spasms or tremors of any kind
  • Arm arteriovenous fistula
  • Inability to cooperate due to impaired cognition

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: CROSS_SECTIONAL

코호트 및 개입

그룹/코호트
개입 / 치료
Group 1 Asymptomatic

Participants with one or more CVD risk factors
장치: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

장치: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 2a Suspected PAD (intermittent claudication)

Partcipants presenting with Suspected PAD (intermittent claudication)
장치: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

장치: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 2b Suspected PAD (CLTI)

Participants presenting with tissue loss or rest pain
장치: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

장치: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 3 Post-bypass surveillance

Participants presenting for post-bypass surveillance
장치: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

장치: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Diagnostic Accuracy
기간: From enrolment to the end of treatment (1 day)

Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV).
From enrolment to the end of treatment (1 day)

2차 결과 측정

결과 측정
측정값 설명
기간
Validity assessed via correlation
기간: Data collected at enrolment (1 day)

Diagnostic performance assessed via area under the receiver operating characteristic (AUROC) curve and the assessment time difference, assessed via measurement of the time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Data collected at enrolment (1 day)
Diagnostic performance
기간: Data collected at enrolment (1 day)

Assessed via area under the receiver operating characteristic (AUROC) curve.
Data collected at enrolment (1 day)
Time taken to perform each automated ABPI assessment and the manual ABPI assessment.
기간: Data collected at enrolment (1 day)

Time taken to perform each assessment in seconds
Data collected at enrolment (1 day)
Qualitative Workstream - Assessment of usability and tolerability of automated devices.
기간: Within the 2 year recruitment period

Semi structured interviews analysed using thematic analysis
Within the 2 year recruitment period
Visual Analogue Scale (VAS) score of 0-10
기간: Data collected at point of enrolment (1 day)

VAS used to assess tolerability
Data collected at point of enrolment (1 day)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hull University Teaching Hospitals NHS Trust

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 24일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2028년 9월 1일

연구 등록 날짜

최초 제출

2026년 9월 14일

QC 기준을 충족하는 최초 제출

2026년 9월 24일

처음 게시됨 (실제)

2026년 9월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 30일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R4364

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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