Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL112986 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.
Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonsusceptible Smokers (NS) | Experimental | 8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
|
| Susceptible Smokers (SS) | Experimental | 11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil study group | Drug | One dose of 20 mg Sildenafil will be given one hour before CT imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration | Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil. | Change of perfused blood volume from baseline at one hour after sildenafil administration. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
For the subjects that will receive Sildenafil as part of the study, additional exclusion criteria are as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric A Hoffman | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20368443 | Result | Alford SK, van Beek EJ, McLennan G, Hoffman EA. Heterogeneity of pulmonary perfusion as a mechanistic image-based phenotype in emphysema susceptible smokers. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7485-90. doi: 10.1073/pnas.0913880107. Epub 2010 Apr 5. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Data Distribution | Individual Participant Data Set | View IPD |
CT images will be shared including non-contrast images at Total Lung Capacity (TLC), Functional Residual Capacity (FRC) and Residual Volume (RV) as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
Data will be made available starting 6 months after publication of the primary results of each aim.
Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, Ph.D. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. This costs will not exceed $250. This service will be available for a minimum of 2 years of study close.
Not provided
Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications leaving 8NS and 11SS subjects.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nonsusceptible Smokers (NS) | 22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil. One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS. |
| FG001 | Susceptible Smoker (SS) | 22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil. One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nonsusceptible Smokers (NS) | 8 emphysema nonsusceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects |
| 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 | Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration | Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil. | Posted | Mean | Standard Deviation | coefficient of variation | Change of perfused blood volume from baseline at one hour after sildenafil administration. |
|
Through study completion, one study visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonsusceptible Smokers (NS) | 8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Hoffman, PhD | University of Iowa | 319-365-1381 | eric-hoffman@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG001 |
| Susceptible Smokers (SS) |
11 emphysema susceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Susceptible Smoker (SS) |
10 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, one dose of 20 mg Sildenafil was administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. One dose of 20 mg Sildenafil will be given one hour before CT imaging. |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Susceptible Smokers (SS) | 11 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |