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

Infant,Premature Clinical Trial

— PET-MRI  

Official title:

Cardiac Function and Metabolism in Young Adults Born Premature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245723
• Other study ID #: 2017-0238
• Secondary ID: UL1TR000427A5342
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: February 26, 2020

Study information

• Verified date: January 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infant,Premature
• Premature Birth

Intervention

Procedure:
• Pulmonary Function Testing
Subjects will undergo Spirometry and Plethysmography
• Electrocardiogram
Subjects will undergo an electrocardiogram to ensure sinus rhythm
• Positron Emission Tomography
Subjects will undergo positron emission tomography to detect images of the heart
• Magnetic Resonance Imaging
Subjects will undergo positron magnetic resonance imaging to detect images of the heart

Locations

Country	Name	City	State
United States	UW Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	American Heart Association, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Glucose Uptake During Normoxic Rest (µg/Min)	Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.	Visit 1 (1 day)
Primary	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)