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

University of Wisconsin (UW)

Status: Completed

Conditions: Infant,Premature

Treatments: Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Pulmonary Function Testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03245723

2017-0238

A534285 (Other Identifier)

UL1TR000427 (U.S. NIH Grant/Contract)

SMPH/MEDICINE/MEDICINE*P (Other Identifier)

Protocol Version 4/23/2019 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

Preterm

Active Comparator group

Description:

Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years). All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Magnetic Resonance Imaging

Procedure: Electrocardiogram

Procedure: Pulmonary Function Testing

Term - Healthy Controls

Placebo Comparator group

Description:

Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Magnetic Resonance Imaging

Procedure: Electrocardiogram

Procedure: Pulmonary Function Testing