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Completed

NCT Number: NCT03245723

Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.

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Key information

Conditions

Infant,Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Madison

Madison, Wisconsin, 53792, United States

About this study

The purpose of this study is to determine the effects of premature birth on cardiac function, cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration studies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • National Lung Project Cohort only- birth weight <1500g and a gestational age <36 weeks
  • Adults born preterm (Non-National Lung Project) only- gestational age ≤32 weeks OR birth weight ≤ 3lbs 5oz
  • Healthy Controls only- No personal history of known cardiovascular or pulmonary disease

Exclusion criteria

  • Metabolic Disorders that would affect Fludeoxyglucose uptake
  • Contraindications to positron emission tomography and/or magnetic resonance imaging
  • Pregnancy, if a female of child-bearing potential
  • A personal history of Type I or Type II diabetes

Treatment and study plan

Pulmonary Function Testing

Procedure

Subjects will undergo Spirometry and Plethysmography

Electrocardiogram

Procedure

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Positron Emission Tomography

Procedure

Subjects will undergo positron emission tomography to detect images of the heart

Magnetic Resonance Imaging

Procedure

Subjects will undergo positron magnetic resonance imaging to detect images of the heart

Primary outcomes

  1. Cardiac Glucose Uptake During Normoxic Rest (µg/Min)

    Time frame: Visit 1 (1 day)

    Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

  2. Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)

    Time frame: Visit 1 (1 day)

    Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American Heart Association
  • National Institutes of Health (NIH)

Registry information

Official study title

Cardiac Function and Metabolism in Young Adults Born Premature

Acronym: PET-MRI

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2017
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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