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Preterm Birth and Long Term Consequences on Myocardial Functions and Structure (PREMACOEUR)

Primary Purpose

Preterm Birth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic resonance imaging (MRI)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Birth

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Exclusion Criteria:Medical history of:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Preterm group

    control group

    Arm Description

    young adults born preterm will performed an Magnetic resonance imaging (MRI)

    young adults born at term will performed an Magnetic resonance imaging (MRI)

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2017
    Last Updated
    July 4, 2018
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03589365
    Brief Title
    Preterm Birth and Long Term Consequences on Myocardial Functions and Structure
    Acronym
    PREMACOEUR
    Official Title
    Preterm Birth and Long Term Consequences on Myocardial Functions and Structure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preterm group
    Arm Type
    Other
    Arm Description
    young adults born preterm will performed an Magnetic resonance imaging (MRI)
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    young adults born at term will performed an Magnetic resonance imaging (MRI)
    Intervention Type
    Other
    Intervention Name(s)
    Magnetic resonance imaging (MRI)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Left ventricular mass
    Description
    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.
    Time Frame
    45 minutes
    Title
    Left ventricular volume
    Description
    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.
    Time Frame
    45 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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. Exclusion Criteria:Medical history of: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Farid BOUBRED
    Phone
    0491384041
    Email
    farid.boubred@ap-hm.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    EMILIE GARRIDO PRADALIE
    Organizational Affiliation
    Assistance Publique Hôpitaux de Marseille
    Official's Role
    Study Director

    12. IPD Sharing Statement

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