The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health (EPOCH)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Paul Leeson, PhD, FRCP
- Telefonní číslo: +44(0)1865572846
- E-mail: paul.leeson@cardiov.ox.ac.uk
Studijní místa
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Oxfordshire
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Oxford, Oxfordshire, Spojené království, OX3 9DU
- Nábor
- Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
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Kontakt:
- Paul Leeson, PhD, MRCP
- E-mail: paul.leeson@cardiov.ox.ac.uk
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Vrchní vyšetřovatel:
- Paul Leeson, PhD, FRCP
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Systolic Cardiac Function
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Micro-vascular Structure
Časové okno: 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
Časové okno: Birth and 3 months
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Birth and 3 months
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Cardiac Structure
Časové okno: 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
Časové okno: 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
Časové okno: Birth and 3 months
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Birth and 3 months
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Heart rate variability
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Paul Leeson, PhD, FRCP, University of Oxford Department of Cardiovascular Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EPOCH
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