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| Name | Class |
|---|---|
| Cereno Scientific AB | INDUSTRY |
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Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT Pulmonary Angiography Recipient | All subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Pulmonary Angiography Scan | Diagnostic Test | Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of BV5A to BV10A | Change from baseline to month 12 in the ratio BV5A/BV10A | From baseline CT scan to 12 month CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of BV5A to BV5APR | Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable. | From baseline CT scan to 12 month CT scan |
| Ratio of BV5A to BV5APRA |
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Inclusion Criteria:
Exclusion Criteria:
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Participation in the CS1-004 clinical trial at Prisma Health-Upstate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. US EPA O. Frequent Questions: Radiation in Medicine. www.epa.gov. Published December 4, 2023. https://www.epa.gov/radiation/frequent-questions-radiation-medicine |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2026 | |
| Reset | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 1, 2026 |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.
| From baseline CT scan to 12 month CT scan |