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

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Preterm-born Young Adults
Term-born Young Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac structure	Left ventricular mass	Young adulthood

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function	Global longitudinal strain and diastolic strain rate	Young adulthood
Arterial stiffness	Pulse wave velocity	Young adulthood
Microvascular structure	Capillary density	Young adulthood
Cardiac structure	Right ventricular mass	Young Adulthood

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Paul Leeson, PhD, MRCP, Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford

Publications and helpful links

General Publications

• Lewandowski AJ, Lamata P, Francis JM, Piechnik SK, Ferreira VM, Boardman H, Neubauer S, Singhal A, Leeson P, Lucas A. Breast Milk Consumption in Preterm Neonates and Cardiac Shape in Adulthood. Pediatrics. 2016 Jul;138(1):e20160050. doi: 10.1542/peds.2016-0050. Epub 2016 Jun 14.
• Lewandowski AJ, Augustine D, Lamata P, Davis EF, Lazdam M, Francis J, McCormick K, Wilkinson AR, Singhal A, Lucas A, Smith NP, Neubauer S, Leeson P. Preterm heart in adult life: cardiovascular magnetic resonance reveals distinct differences in left ventricular mass, geometry, and function. Circulation. 2013 Jan 15;127(2):197-206. doi: 10.1161/CIRCULATIONAHA.112.126920. Epub 2012 Dec 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2007
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (ESTIMATE): December 7, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Early Vascular Study