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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000427 | U.S. NIH Grant/Contract | View source | |
| A534285 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/MEDICINE*P | Other Identifier | UW Madison | |
| Protocol Version 4/23/2019 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| American Heart Association | OTHER |
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The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Function Testing | Procedure | Subjects will undergo Spirometry and Plethysmography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara N Goss, MD | The University of Wisconsin School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Madison | Madison | Wisconsin | 53792 | United States |
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Out of 52 enrolled participants, no data was collected for 2 participants due to COVID. 50 participants were allocated to intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Current age of participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Glucose Uptake During Normoxic Rest (µg/Min) | Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI. | Data was not collected for 4 preterm participants due to following reasons:
| Posted | Mean | Standard Deviation | µg/min | Visit 1 (1 day) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kara Goss | UT Southwestern Medical Center, Dallas, Texas | 214-648-6868 | kara.goss@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 | Jan 13, 2021 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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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.
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| Electrocardiogram | Procedure | Subjects will undergo an electrocardiogram to ensure sinus rhythm |
|
| Positron Emission Tomography | Procedure | Subjects will undergo positron emission tomography to detect images of the heart |
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| Magnetic Resonance Imaging | Procedure | Subjects will undergo positron magnetic resonance imaging to detect images of the heart |
|
| Having to abruptly stop the scan to use the restroom |
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| Image acquisition/reconstruction failure |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Gestational age (Neonatal Characteristics) | Neonatal characteristics-gestational age of participants at the time of birth | Mean | Standard Deviation | Weeks |
|
| Birth weight (Neonatal Characteristics) | Mean | Standard Deviation | Grams |
|
| OG001 | 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 |
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| Primary | Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) | Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI. | 5 preterm and 1 term participants did nor receive the allocated intervention due to :
| Posted | Mean | Standard Deviation | µg/min | Visit 1 (1 day) |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
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| D000091642 | Urogenital Diseases |