What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood? (EVS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01487824
First received: December 5, 2011
Last updated: June 19, 2012
Last verified: June 2012
  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

Further study details as provided by University of Oxford:

Biospecimen Retention:   Samples With DNA

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487824

Contacts
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

Locations
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)         
Sponsors and Collaborators
University of Oxford
Investigators
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 September 18, 2014