Preterm BirthPREMACOEURNCT03589365
Preterm Birth and Long Term Consequences on Myocardial Functions and Structure
A study testing Magnetic resonance imaging (MRI) in people with Preterm Birth, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jan 2020
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For the subjects of the group "Préma":
- age between 18 and 30 years, registered with the French social security system, And signed an informed consent form for the study
- gestational age at birth below 34 years
- no growth restriction in utero (birth weight for age Gestational superior to the 10th percentile)
- matching to term subjects on sex, tobacco consumption And age
- not participating in other studies
Show all 13Show fewer
- For the subjects of the "Witness" group:
- age between 18 and 30 years, registered with the French social security system, And having participated in the study Marseille DOHaD Study
- gestational age between 37 and 41 SA
- birth weight between 25th and 75th percentile
- Cardiac MRI, complete data
- For all patients:
- Available growth data (health records) including weights And sizes at birth, then at 4 months, 9 months, 2 years, 6 years and 12 years The investigator should ensure by consulting the "National Biomedical research "that the subject is not in a period of exclusion from Other test.
Who cannot join
- Congenital heart disease Endocrine or chronic renal disease Acquired metabolic disease in childhood Non-idiopathic hypertension Malignant disease Obesity related to a characteristic pathology. Any physical or psychological condition that would jeopardize the participation of the subject in the research protocol.- Pregnancy in progress.
- Contra-indications to the realization of an MRI: pacemaker Heart valve prosthesis Intracranial surgery Possibility of having received metal projectiles (splinters Metallic, bullets, shrapnel, etc.) Working in metals Presence of prostheses claustrophobia
Trial locations and contacts
No sites are listed yet.
About this study
Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known.
However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford)
Read the detailed description
Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known.
However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford) The aims of this study are to evaluate the effects of preterm birth on heart functions and in a cohort of healthy young adults born preterm. Early alterations could be observed, before the onset of disease. This study will include 60 young adults aged from 18 to 30 years, 30 of them born preterm (Preterm group) and 30 born at term with normal birth weight (Control group). The groups will be matched for age and gender and tobacco exposition.
Young adults born preterm who will be included in the study were born and followed-up in the Neonatal Unit, APHM, in Marseille. Data from the Control adult born at term are well known and available (Marseille DOHaD Study, D.Barker (University of Southampton, England) and K.Thornburg (OHSU Portland, USA)).
This study addresses the mechanism underlying the association between cardiovascular diseases and preterm birth, and aims to identify early predictive markers in order to guide long term follow-up of these young adults. The results of this study will help to develop specific and accurate diagnostic tools and to implement preventive nutritional or pharmacological strategies.
- Conditions
- Preterm Birth
- Being tested
- Magnetic resonance imaging (MRI)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Other
Compare the left ventricular mass of a young adult population born prematurely (Prema group) to that of a group of young adults born at term (Witness group
The measurements made during this examination are:
Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume
The measurements made during this examination are:
Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume
| Study group | Role | What they receive |
|---|---|---|
| Preterm group | Other | young adults born preterm will performed an Magnetic resonance imaging (MRI) Receives: Other: Magnetic resonance imaging (MRI) |
| control group | Other | young adults born at term will performed an Magnetic resonance imaging (MRI) Receives: Other: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass
Left ventricular mass will be determined (in mg/m²) by tracing the endo and epicardial contours, including the papillary muscles, on end-systole images and late diastole images from the base to the apex. Two different observers will carry out all the measures.
Measured: 45 minutes
Left ventricular volume
Left ventricular volume will be determined (in ml) by tracing the endo and epicardial contours, including the papillary muscles, on end-systole images and late diastole images from the base to the apex. Two different observers will carry out all the measures.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589365
- Sponsor's protocol ID
- 2017-14
- Acronym
- PREMACOEUR
- Status last verified
- Jul 2018
- First submitted
- 22 Aug 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Birth and Long Term Consequences on Myocardial Functions and Structure
- ClinicalTrials.gov ID
- NCT03589365
- Acronym / sponsor ID
- PREMACOEUR / 2017-14
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- 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.
Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known.
However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford)
Detailed description
Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known.
However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford) The aims of this study are to evaluate the effects of preterm birth on heart functions and in a cohort of healthy young adults born preterm. Early alterations could be observed, before the onset of disease. This study will include 60 young adults aged from 18 to 30 years, 30 of them born preterm (Preterm group) and 30 born at term with normal birth weight (Control group). The groups will be matched for age and gender and tobacco exposition.
Young adults born preterm who will be included in the study were born and followed-up in the Neonatal Unit, APHM, in Marseille. Data from the Control adult born at term are well known and available (Marseille DOHaD Study, D.Barker (University of Southampton, England) and K.Thornburg (OHSU Portland, USA)).
This study addresses the mechanism underlying the association between cardiovascular diseases and preterm birth, and aims to identify early predictive markers in order to guide long term follow-up of these young adults. The results of this study will help to develop specific and accurate diagnostic tools and to implement preventive nutritional or pharmacological strategies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm group | Other | Other: Magnetic resonance imaging (MRI)young adults born preterm will performed an Magnetic resonance imaging (MRI) |
| control group | Other | Other: Magnetic resonance imaging (MRI)young adults born at term will performed an Magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- age between 18 and 30 years, registered with the French social security system, And signed an informed consent form for the study
- gestational age at birth below 34 years
- no growth restriction in utero (birth weight for age Gestational superior to the 10th percentile)
- matching to term subjects on sex, tobacco consumption And age
- not participating in other studies
Key exclusion criteria (2 listed)
- Congenital heart disease Endocrine or chronic renal disease Acquired metabolic disease in childhood Non-idiopathic hypertension Malignant disease Obesity related to a characteristic pathology. Any physical or psychological condition that would jeopardize the participation of the subject in the research protocol.- Pregnancy in progress.
- Contra-indications to the realization of an MRI: pacemaker Heart valve prosthesis Intracranial surgery Possibility of having received metal projectiles (splinters Metallic, bullets, shrapnel, etc.) Working in metals Presence of prostheses claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (MRI)Compare the left ventricular mass of a young adult population born prematurely (Prema group) to that of a group of young adults born at term (Witness group The measurements made during this examination are: Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume The measurements made during this examination are: Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume | Other | Preterm group, control group |
Primary outcome
Left ventricular mass
Time frame: 45 minutes
Left ventricular mass will be determined (in mg/m²) by tracing the endo and epicardial contours, including the papillary muscles, on end-systole images and late diastole images from the base to the apex. Two different observers will carry out all the measures.
Left ventricular volume
Time frame: 45 minutes
Left ventricular volume will be determined (in ml) by tracing the endo and epicardial contours, including the papillary muscles, on end-systole images and late diastole images from the base to the apex. Two different observers will carry out all the measures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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.
EMILIE GARRIDO PRADALIE study director
Assistance Publique Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging (MRI) in people with Preterm Birth, run by Assistance Publique Hopitaux De Marseille.
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 13 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farid BOUBRED (0491384041, farid.boubred@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass (time frame: 45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.