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

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ClinicalTrials.gov Identifier: NCT03245723
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
American Heart Association
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infant,Premature Procedure: Pulmonary Function Testing Procedure: Electrocardiogram Procedure: Positron Emission Tomography Procedure: Magnetic Resonance Imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Cardiac Function and Metabolism in Young Adults Born Premature
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020

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: Pulmonary Function Testing
Subjects will undergo Spirometry and Plethysmography

Procedure: Electrocardiogram
Subjects will undergo an electrocardiogram to ensure sinus rhythm

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: Pulmonary Function Testing
Subjects will undergo Spirometry and Plethysmography

Procedure: Electrocardiogram
Subjects will undergo an electrocardiogram to ensure sinus rhythm

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




Primary Outcome Measures :
  1. Cardiac Glucose Uptake During Normoxic Rest (µg/Min) [ Time Frame: Visit 1 (1 day) ]
    Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

  2. Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) [ Time Frame: Visit 1 (1 day) ]
    Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245723


Locations
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United States, Wisconsin
UW Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
American Heart Association
Investigators
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Principal Investigator: Kara N Goss, MD The University of Wisconsin School of Medicine and Public Health
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03245723    
Other Study ID Numbers: 2017-0238
UL1TR000427 ( U.S. NIH Grant/Contract )
A534285 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*P ( Other Identifier: UW Madison )
Protocol Version 4/23/2019 ( Other Identifier: UW Madison )
First Posted: August 10, 2017    Key Record Dates
Results First Posted: February 4, 2021
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
premature adults
premature
premature lung function
premature cardiac function
MRI
PET
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications