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

NCT ID: NCT01487824

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preterm Birth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm-born Young Adults

No interventions assigned to this group

Term-born Young Adults

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Leeson, PhD, MRCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27302980 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23224059 (View on PubMed)

Other Identifiers

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Early Vascular Study

Identifier Type: -

Identifier Source: org_study_id

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