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Completed

NCT Number: NCT01487824

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cardiac structure

    Time frame: Young adulthood

    Left ventricular mass

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Acronym: EVS

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Dec 7, 2011
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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