Clinical trial NCT05843461: PIMR and Pulmonary Vascular Disease
Official title: The Pulmonary Index of Microcirculatory Resistance: a Novel Hemodynamic Index for Invasively Assessing the Pulmonary Vasculature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Index of Microcirculatory Resistance
Chronic Thromboembolic Disease
Pulmonary Index of Microcirculatory Resistance
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo standard-of-care right and left heart catheterization either for evaluation of suspected or known pulmonary hypertension (PAH or CTEPH) or for lung transplant evaluation in the setting of advanced lung disease

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* Contraindicated to undergo fluoroscopy and/or coronary angiography (e.g. pregnancy)
* Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)

Primary outcomes:
measure: Pulmonary Index of Microcirculatory Resistance (PIMR)
timeFrame: Baseline
measure: Right Ventricle Index of Microcirculatory Resistance (RV-IMR)
timeFrame: Baseline
measure: OCT-derived pulmonary artery wall thickness
timeFrame: Baseline
measure: OCT-derived thickness-diameter ratio
timeFrame: Baseline
measure: OCT-derived wall-area ratio
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rushi Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: