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

Primary Purpose

Infant,Premature

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Function Testing
Electrocardiogram
Positron Emission Tomography
Magnetic Resonance Imaging
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infant,Premature focused on measuring premature adults, premature, premature lung function, premature cardiac function, MRI, PET

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts 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

Sites / Locations

  • UW Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Preterm

Term - Healthy Controls

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 8, 2017
Last Updated
February 2, 2021
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT03245723
Brief Title
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)
Acronym
PET-MRI
Official Title
Cardiac Function and Metabolism in Young Adults Born Premature
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH), American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant,Premature
Keywords
premature adults, premature, premature lung function, premature cardiac function, MRI, PET

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Young adults born premature (some of them are registered on the National Lung Project) and Healthy Controls will undergo pulmonary function testing, cardiac positron emission tomography, and cardiac magnetic resonance imaging.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preterm
Arm Type
Active Comparator
Arm 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.
Arm Title
Term - Healthy Controls
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Function Testing
Intervention Description
Subjects will undergo Spirometry and Plethysmography
Intervention Type
Procedure
Intervention Name(s)
Electrocardiogram
Intervention Description
Subjects will undergo an electrocardiogram to ensure sinus rhythm
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Intervention Description
Subjects will undergo positron emission tomography to detect images of the heart
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Primary Outcome Measure Information:
Title
Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
Description
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Time Frame
Visit 1 (1 day)
Title
Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)
Description
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Time Frame
Visit 1 (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara N Goss, MD
Organizational Affiliation
The University of Wisconsin School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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