- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00520312
Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease
Magnetic Resonance in Peripheral Arterial Disease
연구 개요
상태
정황
상세 설명
Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. This study will use MRI techniques to examine how characteristics of plaque build-up in the leg arteries change over time and how this change affects function, walking ability, leg strength, and balance in people with PAD. Results from this study may be used to shape future research studies that will attempt to identify more effective treatments for people with PAD.
This study will enroll people with PAD, as well as a smaller control group of people who do not have PAD. At an initial study visit, study researchers will interview participants to collect information about their medical history, daily activity level, walking ability, and mental functioning. Blood collection and a leg MRI will occur. Also, blood flow to the legs will be measured by comparing blood pressure measurements in the arms and legs. Leg function will be measured through a series of timed walks, leg strength exercises, and muscle power exercises. Questionnaires to assess participants' medical history will be completed by each participant's primary care doctor, and study researchers will review participants' medical records. Participants with knee pain will have a knee x-ray, and participants may wear a small device called an accelerometer for 1 week to monitor physical activity levels. During the second and third study visits, occurring at one and two year follow-up, blood flow, leg function, and leg strength will be measured. If participants cannot attend either study visit, researchers may visit participants at their home or conduct an interview over the phone. Study researchers may contact participants by phone once or twice a year for follow-up.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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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:
- For participants with PAD: lowest leg ankle-brachial index (ABI) less than or equal to 0.999
- For participants in the control group: lowest ABI between 1.00 to 1.30
Exclusion Criteria:
- Foot amputation, leg amputation, or gangrene
- Recent liver transplantation
- Requires oxygen on ambulation
- End stage renal disease
- Confined to a wheelchair
- Lives in a nursing home
- Low life expectancy
- Mini-Mental Status Exam (MMSE) score of less than 23 out of 30
- Communication difficulty due to language barriers
- Inability to tolerate MRI testing for any reason
- Six-minute walk performance limited primarily by pulmonary disease, legal blindness, or severe lower extremity arthritis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Functional Performance: 6-minute walk performance
기간: Baseline, 12 months, 24 months
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Baseline, 12 months, 24 months
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MRI: Mean Plaque Volume
기간: Baseline, 24 months
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Baseline, 24 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Four meter walking velocity (usual pace), four meter walking velocity (fastest pace), SPPB
기간: Baseline, 12 months, 24 months
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Baseline, 12 months, 24 months
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MRI: maximum plaque volume, external remodeling, mean percent lumen reduction, maximum percent lumen reduction
기간: Baseline, 24 months
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Baseline, 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mary M. McDermott, MD, Northwestern University
간행물 및 유용한 링크
일반 간행물
- Polonsky TS, Liu K, Tian L, Carr J, Carroll TJ, Berry J, Criqui MH, Ferrucci L, Guralnik JM, Kibbe MR, Kramer CM, Li F, Xu D, Zhao X, Yuan C, McDermott MM. High-risk plaque in the superficial femoral artery of people with peripheral artery disease: prevalence and associated clinical characteristics. Atherosclerosis. 2014 Nov;237(1):169-76. doi: 10.1016/j.atherosclerosis.2014.08.034. Epub 2014 Sep 2.
- McDermott MM, Carroll TJ, Kibbe M, Kramer CM, Liu K, Guralnik JM, Keeling AN, Criqui MH, Ferrucci L, Yuan C, Tian L, Liao Y, Berry J, Zhao L, Carr J. Proximal superficial femoral artery occlusion, collateral vessels, and walking performance in peripheral artery disease. JACC Cardiovasc Imaging. 2013 Jun;6(6):687-94. doi: 10.1016/j.jcmg.2012.10.024. Epub 2013 May 4.
- McDermott MM, Liu K, Carr J, Criqui MH, Tian L, Li D, Ferrucci L, Guralnik JM, Kramer CM, Yuan C, Kibbe M, Pearce WH, Berry J, McCarthy W, Liao Y, Xu D, Orozco J, Carroll TJ. Superficial femoral artery plaque, the ankle-brachial index, and leg symptoms in peripheral arterial disease: the walking and leg circulation study (WALCS) III. Circ Cardiovasc Imaging. 2011 May;4(3):246-52. doi: 10.1161/CIRCIMAGING.110.962183. Epub 2011 Mar 24.
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. .
말초 혈관 질환에 대한 임상 시험
-
C. R. Bard완전한
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Mayo Clinic초대로 등록
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국