- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01147952
The Effect of Exercise on Peripheral Blood Gene Expression in Angina
A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.
We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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South Yorkshire
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Sheffield, South Yorkshire, 영국, S5 7AU
- NIHR Cardiovascular Biomedical Research Unit
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography
- Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme.
Exclusion Criteria:
- Acute coronary syndromes or recent myocardial infarction (<2 months)
- Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis
- Known reduced left ventricular function (ejection fraction <40%)
- Significant valvular heart disease
- Insulin-dependent diabetes mellitus
- Occupational, orthopedic, and other conditions that preclude regular exercise
- Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation).
- Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 12 week exercise training
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randomised to 12 weeks of exercise training up to three times weekly.
Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
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간섭 없음: Conventional Care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Peripheral blood gene expression
기간: baseline
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baseline
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Peripheral blood gene expression
기간: 6wks after starting 12week exercise training (or conventional care)
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6wks after starting 12week exercise training (or conventional care)
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peripheral blood gene expression
기간: 12 weeks after exercise training (or conventional care)
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12 weeks after exercise training (or conventional care)
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Peripheral blood gene expression
기간: 24 weeks after starting 12 weeks exercise training programme
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24 weeks after starting 12 weeks exercise training programme
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Angina status
기간: baseline
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baseline
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Angina status
기간: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Angina status
기간: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Angina Status
기간: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
기간: baseline
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baseline
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Anxiety Score
기간: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
기간: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Anxiety Score
기간: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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Depression Score
기간: 6wks after starting 12 week exercise programme (or conventional care)
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6wks after starting 12 week exercise programme (or conventional care)
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Depression Score
기간: baseline
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baseline
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Depression Score
기간: 12wks after starting 12 week exercise programme (or conventional care)
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12wks after starting 12 week exercise programme (or conventional care)
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Depression Score
기간: 24wks after starting 12 week exercise programme (or conventional care)
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24wks after starting 12 week exercise programme (or conventional care)
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공동 작업자 및 조사자
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. .