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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05843461
Other study ID # IRB#22-001643
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 10, 2023
Est. completion date October 31, 2024

Study information

Verified date January 2024
Source University of California, Los Angeles
Contact Rushi Parikh, MD
Phone 310-825-9011
Email rparikh@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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.
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.
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.

Locations

Country Name City State
United States Ronald Reagan UCLA Medical Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary Index of Microcirculatory Resistance (PIMR) PressureWire advanced to distal third of segmental pulmonary artery (PA) for measurement of pulmonary hemodynamics. The derivation of IMR involves the application of Ohm's law (V=IR) to the coronary microcirculatory circuit, where the relationship between resistance (R) = IMR, voltage (V) = pressure (P), and current (I) = flow (Q) can be expressed as follows: IMR = ?P/Q. ?P = the change in pressure across the microvasculature (mean distal coronary artery pressure [Pd] - coronary venous pressure (Pv); Pv is typically disregarded because it is negligible relative to Pd. Based on the principles of thermodilution, flow is inversely proportion to mean transit time (Q ~ 1/Tmn). Lastly, the minimal achievable resistance occurs during maximal hyperemic flow when all available microvessels have theoretically been recruited. Hence, the calculation of IMR simplifies to the following formula: IMR = Pd (pulmonary artery) x TmnHyp. Baseline
Primary Right Ventricle Index of Microcirculatory Resistance (RV-IMR) PressureWire advanced to distal third of acute marginal branch of the right coronary artery (RCA) for measurement of pulmonary hemodynamics. The derivation of IMR involves the application of Ohm's law (V=IR) to the coronary microcirculatory circuit, where the relationship between resistance (R) = IMR, voltage (V) = pressure (P), and current (I) = flow (Q) can be expressed as follows: IMR = ?P/Q. ?P = the change in pressure across the microvasculature (mean distal coronary artery pressure [Pd] - coronary venous pressure (Pv); Pv is typically disregarded because it is negligible relative to Pd. Based on the principles of thermodilution, flow is inversely proportion to mean transit time (Q ~ 1/Tmn). Lastly, the minimal achievable resistance occurs during maximal hyperemic flow when all available microvessels have theoretically been recruited. Hence, the calculation of IMR simplifies to the following formula: IMR = Pd (RCA marginal branch) x TmnHyp. Baseline
Primary OCT-derived pulmonary artery wall thickness A Dragonfly Optis OCT catheter (Abbott) will be advanced over the PressureWireX to the distal left lower lobe segmental pulmonary artery (luminal diameter < 5 mm and minimal length of 50 mm). OCT images of the pulmonary artery will be recorded via automatic pullback and analyzed offline in a blinded manner. Baseline
Primary OCT-derived thickness-diameter ratio A Dragonfly Optis OCT catheter (Abbott) will be advanced over the PressureWireX to the distal left lower lobe segmental pulmonary artery (luminal diameter < 5 mm and minimal length of 50 mm). OCT images of the pulmonary artery will be recorded via automatic pullback and analyzed offline in a blinded manner. Baseline
Primary OCT-derived wall-area ratio Baseline
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