NCT05843461

PIMR and Pulmonary Vascular Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
OTHER	Pulmonary Index of Microcirculatory Resistance	PIMR measurement involves placing a coronary pressure wire in the pulmonary arteries and making pressure/time measurements during maximal flow down the artery. PIMR of the right and left pulmonary arteries will be obtained.
OTHER	Right Ventricle Index of Microcirculatory Resistance	RV-IMR measurement involves placing a coronary pressure wire in the acute marginal branch of the right coronary artery and making pressure/time measurements during maximal flow down the artery.
OTHER	Pulmonary artery OCT	OCT of the pulmonary artery involves advancing an OCT catheter over the pressure wire to image the pulmonary artery. OCT of the right and left pulmonary arteries will be performed.

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-05-06
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States