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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT03245723
• Collaborator: National Institutes of Health (NIH) (NIH), American Heart Association (Other)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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.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: Sep 20, 2017
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cardiac Glucose Uptake During Normoxic Rest (µg/Min) [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) [Visit 1 (1 day)]

   Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UW Madison	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kara N Goss, MD, The University of Wisconsin School of Medicine and Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 23, 2019

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03245723
• Other Study ID Numbers: 2017-0238; UL1TR000427; A534285; SMPH/MEDICINE/MEDICINE*P; Protocol Version 4/23/2019
• First Posted: Aug 10, 2017
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Premature Birth

Study Results

Participant Flow

Pre-assignment Detail	Out of 52 enrolled participants, no data was collected for 2 participants due to COVID. 50 participants were allocated to intervention.

Arm/Group Title	Preterm	Term - Healthy Controls
Arm/Group Description	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. 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	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. 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
Period Title: Overall Study
STARTED	32	18
COMPLETED	27	17
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Preterm	Term - Healthy Controls	Total
Arm/Group Description	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. 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	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. 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	Total of all reporting groups
Overall Participants	32	18	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.1 (4.2)	25.4 (4.0)	25.75 (4.1)
Sex: Female, Male (Count of Participants)
Female	23 71.9%	10 55.6%	33 66%
Male	9 28.1%	8 44.4%	17 34%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.1%	2 11.1%	3 6%
Not Hispanic or Latino	31 96.9%	16 88.9%	47 94%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.1%	0 0%	1 2%
White	30 93.8%	16 88.9%	46 92%
More than one race	1 3.1%	2 11.1%	3 6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Gestational age (Neonatal Characteristics) (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	29.2 (2.5)	39.8 (1.0)	34.5 (1.75)
Birth weight (Neonatal Characteristics) (Grams) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Grams]	1225 (397)	3397 (572)	2311 (484.5)

Outcome Measures

1. Primary Outcome

Title	Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
Description	Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Time Frame	Visit 1 (1 day)

Outcome Measure Data

Analysis Population Description

Data was not collected for 4 preterm participants due to following reasons: bigeminy precluding hypoxia exposure (N=1), claustrophobia from wearing the mask (N=1), having to abruptly stop the scan to use the restroom (N=2).

Arm/Group Title	Preterm	Term - Healthy Controls
Arm/Group Description	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. 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	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. 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
Measure Participants	28	18
Mean (Standard Deviation) [µg/min]	0.689 (0.546)	0.540 (0.454)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preterm, Term - Healthy Controls
	Comments
	Type of Statistical Test	Other
	Comments	Descriptive statistics
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Wilcoxon Rank Sum test
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

5 preterm and 1 term participants did nor receive the allocated intervention due to : bigeminy precluding hypoxia exposure (N=1 preterm), claustrophobia from wearing the mask (N=1 preterm), having to abruptly stop the scan to use the restroom (N=2 preterm). image acquisition/reconstruction failure (n = 2,1 preterm and 1 term)

Arm/Group Title	Preterm	Term - Healthy Controls
Arm/Group Description	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. 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	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. 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
Measure Participants	27	17
Mean (Standard Deviation) [µg/min]	-0.264 (0.588)	-0.003 (0.390)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preterm, Term - Healthy Controls
	Comments
	Type of Statistical Test	Other
	Comments	Descriptive statistics
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Wilcoxon Rank Sum test
	Comments

Adverse Events

Time Frame	1 day
Arm/Group Title	Preterm		Term - Healthy Controls
Arm/Group Description	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. 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		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. 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
All Cause Mortality
	Preterm		Term - Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)
Serious Adverse Events
	Preterm		Term - Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Preterm		Term - Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.