Clinical trial for Pulmonary Hypertension
Official title Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension
ClinicalTrials.gov ID: NCT06911632
What this study is testing
- What it's testing
- The study will see how well the AI device predicts undiagnosed pulmonary hypertension in ILD patients.
- Who it's for
- Adults who have interstitial lung disease.
- What's involved
- Participants will have an ECG taken that is analyzed by the AI system. They may be randomly assigned to different study groups.
- Time commitment: about 6 months
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older at the time of consent
- A known diagnosis of interstitial lung disease
- Diffusing capacity for carbon monoxide (DLCO) \<30% predicted, collected within 6 months prior to consent
- Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required
You likely can't join if
- A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH))
- A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent
- LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available
- Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions
- A contraindication to RHC exists (for example, pregnancy or mechanical right heart valve)
- Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits
See the full eligibility criteria
- 18 years or older at the time of consent
- A known diagnosis of interstitial lung disease
- Diffusing capacity for carbon monoxide (DLCO) \<30% predicted, collected within 6 months prior to consent
- Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required
- A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH))
- A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent
- LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available
- Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions
- A contraindication to RHC exists (for example, pregnancy or mechanical right heart valve)
- Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits
- There is a severe concomitant illness limiting life expectancy to less than 6 months (at the discretion of the investigator)
- There is a medical or social factor that makes the patient a poor candidate for the study and/or unlikely to be able to comply with the study protocol or complete study procedures (at the discretion of the investigator)
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Riverside, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Bossier City, Louisiana, United States
- Shreveport, Louisiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Royal Oak, Michigan, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- Hannibal, Missouri, United States
- Springfield, Missouri, United States
- Omaha, Nebraska, United States
- Reno, Nevada, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Riverside, California, United States; Denver, Colorado, United States; Orlando, Florida, United States and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.