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NCT05843461 · ClinicalTrials.gov registry record
PIMR and Pulmonary Vascular Disease
A clinical trial, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- 30
- Enrollment target
NCT05843461: Completed study, sponsored by University of California, Los Angeles.
NCT05843461 is a clinical trial that has completed, run by University of California, Los Angeles. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05843461 has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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 pressur
Interventions
- OTHER Pulmonary Index of Microcirculatory Resistance
- OTHER Right Ventricle Index of Microcirculatory Resistance
- OTHER Pulmonary artery OCT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2024-07-31 |
What the finished NCT05843461 record still lists
NCT05843461 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Pulmonary Index of Microcirculatory Resistance is the first listed.
NCT05843461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05843461 about?
NCT05843461 is a clinical study titled "PIMR and Pulmonary Vascular Disease". 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 se...
What is the current status of trial NCT05843461?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2023-01-10. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT05843461?
The interventions under investigation include: Pulmonary Index of Microcirculatory Resistance (OTHER), Right Ventricle Index of Microcirculatory Resistance (OTHER), Pulmonary artery OCT (OTHER).
Who is sponsoring clinical trial NCT05843461?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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