Preterm Birth and Long Term Consequences on Myocardial Functions and Structure

NCT03589365 | Unknown

• 1 other identifier: 2017-14
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  45 minutes

Study Arms (2)

Preterm group

OTHER

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

Other: Magnetic resonance imaging (MRI)

control group

OTHER

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

Other: Magnetic resonance imaging (MRI)

Interventions

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

Preterm group; control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Premature Birth

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• EMILIE GARRIDO PRADALIE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Farid BOUBRED

CONTACT

0491384041; farid.boubred@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: July 17, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 17, 2018

Record last verified: 2018-07