The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI

Prisma Health-Upstate7 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

CT Pulmonary Angiography ScanDIAGNOSTIC_TEST

Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Prisma Health

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Ratio of BV5A to BV10A

Change from baseline to month 12 in the ratio BV5A/BV10A

Time frame: From baseline CT scan to 12 month CT scan

Secondary Outcomes

Ratio of BV5A to BV5APR

Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.

Time frame: From baseline CT scan to 12 month CT scan

Ratio of BV5A to BV5APRA

Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.

Time frame: From baseline CT scan to 12 month CT scan

Data from ClinicalTrials.gov

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