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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245723
Other study ID # 2017-0238
Secondary ID UL1TR000427A5342
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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