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

Not Applicable

Completed

• Conditions: Infant,Premature
• Interventions: Procedure: Pulmonary Function Testing; Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

• Registration Number: NCT03245723
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-10
• Study Start: 2017-09-20
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2021-01
• Results First Submitted: 2021-01-14
• Results First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Results First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preterm	Positron Emission Tomography	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.
Preterm	Pulmonary Function Testing	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.
Preterm	Magnetic Resonance Imaging	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.
Term - Healthy Controls	Pulmonary Function Testing	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.
Preterm	Electrocardiogram	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.
Term - Healthy Controls	Magnetic Resonance Imaging	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.
Term - Healthy Controls	Electrocardiogram	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.
Term - Healthy Controls	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
Cardiac Glucose Uptake During Normoxic Rest (µg/Min)	Visit 1 (1 day)	Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)	Visit 1 (1 day)	Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

Trial Locations

Locations (1)

UW Madison; 🇺🇸 Madison, Wisconsin, United States