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

NCT03245723 | Completed Results

• 5 other identifiers: 2017-0238UL1TR000427A534285SMPH/MEDICINE/MEDICINE*PProtocol Version 4/23/2019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infant,Premature

Keywords

premature adults; premature; premature lung function; premature cardiac function; MRI; PET

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Preterm

ACTIVE COMPARATOR

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; Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

Term - Healthy Controls

PLACEBO COMPARATOR

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; Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

Interventions

Pulmonary Function Testing PROCEDURE

Subjects will undergo Spirometry and Plethysmography

Preterm; Term - Healthy Controls

Electrocardiogram PROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Preterm; Term - Healthy Controls

Positron Emission Tomography PROCEDURE

Subjects will undergo positron emission tomography to detect images of the heart

Preterm; Term - Healthy Controls

Magnetic Resonance Imaging PROCEDURE

Subjects will undergo positron magnetic resonance imaging to detect images of the heart

Preterm; Term - Healthy Controls

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• American Heart Association: collaborator

Study Sites (1)

UW Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Respiratory Physiological Phenomena; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Kara Goss
• Organization: UT Southwestern Medical Center, Dallas, Texas

kara.goss@utsouthwestern.edu

214-648-6868

Study Officials

• Kara N Goss, MD

  The University of Wisconsin School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 10, 2017
• Study Start: September 20, 2017
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)