Trial Outcomes & Findings for Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI) (NCT NCT03245723)
NCT ID: NCT03245723
Last Updated: 2021-02-04
Results Overview
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Visit 1 (1 day)
Results posted on
2021-02-04
Participant Flow
Out of 52 enrolled participants, no data was collected for 2 participants due to COVID. 50 participants were allocated to intervention.
Participant milestones
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
18
|
|
Overall Study
COMPLETED
|
27
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
Bigeminy precluding hypoxia exposure
|
1
|
0
|
|
Overall Study
Claustrophobia from wearing the mask
|
1
|
0
|
|
Overall Study
Having to abruptly stop the scan to use the restroom
|
2
|
0
|
|
Overall Study
Image acquisition/reconstruction failure
|
1
|
1
|
Baseline Characteristics
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)
Baseline characteristics by cohort
| Measure |
Preterm
n=32 Participants
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
|
Term - Healthy Controls
n=18 Participants
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
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
25.75 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gestational age (Neonatal Characteristics)
|
29.2 Weeks
STANDARD_DEVIATION 2.5 • n=5 Participants
|
39.8 Weeks
STANDARD_DEVIATION 1.0 • n=7 Participants
|
34.5 Weeks
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Birth weight (Neonatal Characteristics)
|
1225 Grams
STANDARD_DEVIATION 397 • n=5 Participants
|
3397 Grams
STANDARD_DEVIATION 572 • n=7 Participants
|
2311 Grams
STANDARD_DEVIATION 484.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (1 day)Population: 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).
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Outcome measures
| Measure |
Preterm
n=28 Participants
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
|
Term - Healthy Controls
n=18 Participants
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
|
|---|---|---|
|
Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
|
0.689 µg/min
Standard Deviation 0.546
|
0.540 µg/min
Standard Deviation 0.454
|
PRIMARY outcome
Timeframe: Visit 1 (1 day)Population: 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)
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Outcome measures
| Measure |
Preterm
n=27 Participants
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
|
Term - Healthy Controls
n=17 Participants
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
|
|---|---|---|
|
Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)
|
-0.264 µg/min
Standard Deviation 0.588
|
-0.003 µg/min
Standard Deviation 0.390
|
Adverse Events
Preterm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Term - Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kara Goss
UT Southwestern Medical Center, Dallas, Texas
Phone: 214-648-6868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place