MedDataX Logo

PIMR and Pulmonary Vascular Disease

NCT ID: NCT05843461

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulmonary Hypertension Pulmonary Arterial Hypertension Index of Microcirculatory Resistance Chronic Thromboembolic Disease Pulmonary Index of Microcirculatory Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Controls

10 patients without pulmonary hypertension (mean PA pressure less than 20 mmHg on RHC)

Pulmonary Index of Microcirculatory Resistance

Intervention Type OTHER

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.

PAH

10 patients with PAH

Pulmonary Index of Microcirculatory Resistance

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

CTEPH

10 patients with CTEPH

Pulmonary Index of Microcirculatory Resistance

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PIMR RV-IMR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rushi V. Parikh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rushi Parikh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB#22-001643

Identifier Type: -

Identifier Source: org_study_id