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

Cardiac Function and Metabolism in Young Adults Born Premature

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

Study Overview

• Status: Completed
• Conditions: Infant,Premature
• Intervention / Treatment: Procedure: Electrocardiogram; Procedure: Pulmonary Function Testing; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preterm; 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.	Procedure: Electrocardiogram; Subjects will undergo an electrocardiogram to ensure sinus rhythm; Procedure: Pulmonary Function Testing; Subjects will undergo Spirometry and Plethysmography; Procedure: Positron Emission Tomography; Subjects will undergo positron emission tomography to detect images of the heart; Procedure: Magnetic Resonance Imaging; Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Placebo Comparator: Term - Healthy Controls; 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.	Procedure: Electrocardiogram; Subjects will undergo an electrocardiogram to ensure sinus rhythm; Procedure: Pulmonary Function Testing; Subjects will undergo Spirometry and Plethysmography; Procedure: Positron Emission Tomography; Subjects will undergo positron emission tomography to detect images of the heart; Procedure: Magnetic Resonance Imaging; Subjects will undergo positron magnetic resonance imaging to detect images of the heart

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institutes of Health (NIH); American Heart Association
• Investigators: Principal Investigator: Kara N Goss, MD, The University of Wisconsin School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: MRI; PET; premature; premature adults; premature cardiac function; premature lung function
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2017-0238; A534285 (Other Identifier: UW Madison); SMPH/MEDICINE/MEDICINE*P (Other Identifier: University of Wisconsin-Madison); UL1TR000427 (U.S. NIH Grant/Contract); Protocol Version 4/23/2019 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No