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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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South Yorkshire
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Sheffield、South Yorkshire、イギリス、S5 7AU
- NIHR Cardiovascular Biomedical Research Unit
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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介入なし:Conventional Care
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Peripheral blood gene expression
時間枠:baseline
|
baseline
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Peripheral blood gene expression
時間枠: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
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
---|---|
Angina status
時間枠:baseline
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baseline
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Angina status
時間枠: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
時間枠: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
時間枠: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
時間枠:baseline
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baseline
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Anxiety Score
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:baseline
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baseline
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Depression Score
時間枠: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
時間枠: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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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