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

Preterm Birth Clinical Trial

— EVS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487824
• Other study ID #: Early Vascular Study
• Status: Completed
• Start date: May 2007
• Est. completion date: October 2015

Study information

• Verified date: June 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United Kingdom	Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac structure	Left ventricular mass	Young adulthood
Secondary	Cardiac function	Global longitudinal strain and diastolic strain rate	Young adulthood
Secondary	Arterial stiffness	Pulse wave velocity	Young adulthood
Secondary	Microvascular structure	Capillary density	Young adulthood
Secondary	Cardiac structure	Right ventricular mass	Young Adulthood