Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

Description

This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.

Conditions

Scleroderma

Study Overview

Study Details

Study overview

This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.

Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD

Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

Condition
Scleroderma
Intervention / Treatment

-

Contacts and Locations

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
  • * age 21-75
  • * No evidence of Scleroderma related Lung disease (ILD)
  • * Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.
  • * Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
  • * Patients with evidence of lung involvement based upon; Thoracic imaging, abnormal Pulmonary Function Tests (PFTs); Forced Vital Capacity( FVC), Forced Expiratory Volume in 1 second (FEV1) or a Diffusion Capacity for Carbon Monoxide (DLCO) \< the Lower Limit of Normal (LLN) or Saturation of Oxygen in arterial blood (SaO2) \< 90% .
  • * Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
  • * \< 21 or \> 75 years of age
  • * Must not be pregnant or had eye surgery within 2 weeks of LCI testing
  • * Must be able to comprehend and sign an IRB approved consent form and complete LCI testing

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Jewish Health,

Richard T Meehan, MD, PRINCIPAL_INVESTIGATOR, National Jewish Health

Study Record Dates

2026-01-15