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

NCT ID: NCT03245723

Last Updated: 2021-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2020-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant,Premature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Pulmonary Function Testing

Intervention Type PROCEDURE

Subjects will undergo Spirometry and Plethysmography

Electrocardiogram

Intervention Type PROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Positron Emission Tomography

Intervention Type PROCEDURE

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

Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

Pulmonary Function Testing

Intervention Type PROCEDURE

Subjects will undergo Spirometry and Plethysmography

Electrocardiogram

Intervention Type PROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Positron Emission Tomography

Intervention Type PROCEDURE

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

Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulmonary Function Testing

Subjects will undergo Spirometry and Plethysmography

Intervention Type PROCEDURE

Electrocardiogram

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Intervention Type PROCEDURE

Positron Emission Tomography

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

Intervention Type PROCEDURE

Magnetic Resonance Imaging

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kara N Goss, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Wisconsin School of Medicine and Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UW Madison

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UL1TR000427

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534285

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/MEDICINE*P

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/23/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0238

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.