What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood? (EVS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate whether early life exposures such as premature birth or exposure to preeclampsia before you are born results in long-term alterations in the cardiovascular system that increase risk of cardiovascular disease development.
| Condition |
|---|
|
Preterm Birth |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood? A 25-Year Follow-up Study of Preterm-born Individuals |
whole blood, serum, plasma, immortalised cell lines
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Preterm-born Young Adults |
| Term-born Young Adults |
Detailed Description:
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.
We have thus designed the Early Vascular Study to investigate the long-term impact of early life exposures, with a particular focus on the impact of preterm birth, in the presence or absence of pregnancy-induced hypertension in the mother, on the cardiovascular system in young adulthood. This study also allows investigation of the long 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. This is combined with blood sample collection to study changes in molecular and metabolic markers and pathways.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Preterm-born Cohort: A cohort of preterm-born young adults who were enrolled, at birth, from five centres in England between 1982 and 1985 into a randomised trial of milk feeding regimes to study the influence of early diet on later cognitive function and cardiovascular disease.
Term-born Cohort: A cohort of controls born at term with normal birthweight now aged between 20 and 40 years to provide age stratified normal ranges for the outcome measures.
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Preterm-born Cohort: Born premature (<37 weeks completed gestation), originally recruited as part of a randomised feeding trial at birth from one of five UK centres between 1982 and 1985.
- Term-born Cohort: Born at term (>37 weeks completed gestation) with normal birth weight for gestational age.
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
Exclusion Criteria:
-The participant may not enter the study if ANY of the following apply:
- Unwilling or unable to give informed consent for participation in the study.
- Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
- Contraindication to Cardiovascular Magnetic Resonance Imaging.
Contacts and Locations| Contact: Paul Leeson, PhD, MRCP | +44(0)1865572846 | paul.leeson@cardiov.ox.ac.uk |
| Contact: Adam Lewandowski, BSc (Hons) | +44(0)1865572831 | adam.lewandowski@cardiov.ox.ac.uk |
| United Kingdom | |
| Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford | Recruiting |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
| Contact: Paul Leeson, PhD, FRCP +441865572846 paul.leeson@cardiov.ox.ac.uk | |
| Sub-Investigator: Adam J Lewandowski, BSc(Hons) | |
| Principal Investigator: | Paul Leeson, PhD, MRCP | Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford |
More Information
No publications provided by University of Oxford
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01487824 History of Changes |
| Other Study ID Numbers: | Early Vascular Study |
| Study First Received: | December 5, 2011 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on June 18, 2013