Pulmonary Arterial Hypertension
Conditions
Keywords
FLUIDDA FRI, FRI
Brief summary
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).
Interventions
DIAGNOSTIC_TESTCT Pulmonary Angiography Scan
Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast
Sponsors
Prisma Health-Upstate
Cereno Scientific AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participation in the CS1-004 clinical trial
Exclusion criteria
* Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia) * Individuals who are pregnant or who become pregnant during the sub-study * eGFR \<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD) * Allergy to Iodine contrast agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of BV5A to BV10A | From baseline CT scan to 12 month CT scan | Change from baseline to month 12 in the ratio BV5A/BV10A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of BV5A to BV5APR | From baseline CT scan to 12 month CT scan | Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable. |
| Ratio of BV5A to BV5APRA | From baseline CT scan to 12 month CT scan | Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable. |
Countries
United States
Outcome results
None listed