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NCT05843461Completed

PIMR and Pulmonary Vascular Disease

The Pulmonary Index of Microcirculatory Resistance: a Novel Hemodynamic Index for Invasively Assessing the Pulmonary Vasculature

Source: ClinicalTrials.gov · Last updated 5 Dec 2024

Brief summary (registry, in English)

The findings from this innovative, first-in-man, prospective pilot study will elucidate the role of PIMR and RV-IMR in pre-capillary PH. The study cohort will consist of patients with pulmonary pressures ranging from normal (advanced lung disease patients undergoing lung transplant evaluation) to severe PH (PAH and CTEPH patients), and thus will allow for identification of a PIMR cutoff. Participants will include: 1) advanced lung disease patients undergoing bilateral heart catheterization as part of their pre-lung transplant work-up, and 2) newly referred patients to PAH and CTEPH clinics undergoing bilateral heart catheterization as part of standard of care work-up. All participants will undergo PIMR testing, and those with pre-capillary PH will also undergo pulmonary OCT and measurement of RV-IMR. The study seeks to define the relationship between PIMR and PH and to establish the PIMR threshold that identifies pulmonary microvascular dysfunction as well as to evaluate the association of PIMR and pulmonary vascular remodeling on OCT in patients with pre-capillary PH. In addition, the study will assess the relationship between RV-IMR and RV pressure overload among patients with pre-capillary PH.

Status (registry)
Completed
Study type
Observational
Enrollment
30 (actual)
First submitted
24 Apr 2023
Start date
10 Jan 2023
Primary completion date
31 Jul 2024
Lead sponsor
University of California, Los Angeles
NCT number
NCT05843461

What you commit to

  • Study type: Observational
  • Participants enrolled: 30
  • From 10 Jan 2023 to the primary completion date, 31 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)

Other

  • Contraindicated to undergo fluoroscopy and/or coronary angiography (e.g. pregnancy)

Who the study is looking for

  • ≥18 years old
  • Able to provide informed written consent.
  • Patients with 1) advanced lung disease requiring standard-of-care bilateral heart catheterization as part of lung transplant evaluation in whom mPAP \< 20 mmHg on RHC, or 2) PAH/CTEPH (i.e. pre-capillary PH) undergoing standard-of-care bilateral heart catheterization as part of their work-up/treatment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ronald Reagan UCLA Medical Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.