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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487824
Recruitment Status : Unknown
Verified June 2012 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : December 7, 2011
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
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 or disease
Preterm Birth

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.

Study Type : Observational
Estimated Enrollment : 250 participants
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
Study Start Date : May 2007
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Preterm-born Young Adults
Term-born Young Adults

Primary Outcome Measures :
  1. Cardiac structure [ Time Frame: Young adulthood ]
    Left ventricular mass

Secondary Outcome Measures :
  1. Cardiac function [ Time Frame: Young adulthood ]
    Global longitudinal strain and diastolic strain rate

  2. Arterial stiffness [ Time Frame: Young adulthood ]
    Pulse wave velocity

  3. Microvascular structure [ Time Frame: Young adulthood ]
    Capillary density

  4. Cardiac structure [ Time Frame: Young Adulthood ]
    Right ventricular mass

Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma, immortalised cell lines

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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.


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 United Kingdom 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01487824

Contact: Paul Leeson, PhD, MRCP +44(0)1865572846
Contact: Adam Lewandowski, BSc (Hons) +44(0)1865572831

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   
Sub-Investigator: Adam J Lewandowski, BSc(Hons)         
Sponsors and Collaborators
University of Oxford
Principal Investigator: Paul Leeson, PhD, MRCP Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Oxford Identifier: NCT01487824     History of Changes
Other Study ID Numbers: Early Vascular Study
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: June 2012

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications