Preterm BirthEVSNCT01487824
What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood?
An observational study of Preterm Birth, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- How many people
- 234 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
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
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.
Read the 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.
- Conditions
- Preterm Birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm-born Young Adults | Not described | |
| Term-born Young Adults | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac structure
Left ventricular mass
Measured: Young adulthood
Secondary outcomes (4)
Cardiac function
Global longitudinal strain and diastolic strain rate
Measured: Young adulthood
Arterial stiffness
Pulse wave velocity
Measured: Young adulthood
Microvascular structure
Capillary density
Measured: Young adulthood
Cardiac structure
Right ventricular mass
Measured: Young Adulthood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startMay 2007
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Leeson, PhD, MRCP, Principal investigator, Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487824
- Sponsor's protocol ID
- Early Vascular Study
- Acronym
- EVS
- Status last verified
- Jun 2012
- First submitted
- 5 Dec 2011
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27302980Lewandowski 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.
PubMed 23224059
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01487824
- Acronym / sponsor ID
- EVS / Early Vascular Study
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm-born Young Adults | – | – |
| Term-born Young Adults | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac structure
Time frame: Young adulthood
Left ventricular mass
4 secondary outcomes
Cardiac function
Time frame: Young adulthood
Arterial stiffness
Time frame: Young adulthood
Microvascular structure
Time frame: Young adulthood
Cardiac structure
Time frame: Young Adulthood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Derived from this study: PubMed 27302980Lewandowski 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.
- Derived from this study: PubMed 23224059Lewandowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Leeson, PhD, MRCP principal investigator
Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac structure (time frame: Young adulthood). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.