The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)
調査の概要
詳細な説明
While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.
The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 9DU
- 募集
- Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
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コンタクト：
- Paul Leeson, PhD, MRCP
- メール：paul.leeson@cardiov.ox.ac.uk
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主任研究者：
- Paul Leeson, PhD, FRCP
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Available for assessment within the neonatal period,
- Parent is willing and able to give informed consent for participation in the study,
- Physical condition is suitable to allow non-invasive vascular testing,
- Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged >/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
- Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (<37 weeks gestation)
- Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (>37 weeks gestation)
Exclusion Criteria:
- Parent is unwilling to give consent,
- Unavailable for assessment of cardiovascular system,
- Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
- Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
- Cardiorespiratory instability at time of proposed measures,
- Active infection at time of proposed study measures,
- Mother of infant is excluded from the study. (Aged <16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)
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
コホートと介入
グループ/コホート |
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Normotensive Term
Infants born at term (>37 weeks) to Normotensive pregnancies
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Term Preeclampsia
Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy
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Preterm Normotensive
Infants born to Normotensive pregnancies at <37 weeks gestation
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Preterm Hypertensive
Infants born to hypertensive pregnancies at <37 weeks completed gestation
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Term Pregnancy-induced Hypertension
Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Systolic Cardiac Function
時間枠：Birth and 3 months
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Cardiac Function will be assessed by ECHO at birth and 3 months
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Birth and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Micro-vascular Structure
時間枠：Birth and 3 months
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Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)
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Birth and 3 months
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Pulse wave velocity and pulse-wave analysis
時間枠：Birth and 3 months
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Birth and 3 months
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Cardiac Structure
時間枠：Birth and 3 months
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Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)
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Birth and 3 months
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Cardiac diastolic function
時間枠：Birth and 3 months
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Cardiac Function will be assessed by ECHO at birth and 3 months
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Birth and 3 months
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Blood pressure
時間枠：Birth and 3 months
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Birth and 3 months
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Heart rate variability
時間枠：Birth and 3 months
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Heart rate variability will be assessed by a 5 minute electrocardiogram
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Birth and 3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Paul Leeson, PhD, FRCP、University of Oxford Department of Cardiovascular Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。