Not provided
Not provided
Not provided
Not provided
Not provided
Study was stopped due to funding and time constraints.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to utilize lung ultrasound to detect the development of extravascular lung water in patients undergoing clinically indicated invasive hemodynamic exercise stress testing for symptomatic shortness of breath. The study will correlate the lung ultrasound findings with cardiac hemodynamics and measurements of extravascular lung water in an effort to better understand the pathophysiology of exertional dyspnea.
Exercise induced elevation of left ventricular (LV) filling pressures can be the source of chronic dyspnea. Ultimately, high LV filling pressure leads to the development of extravascular lung water (EVLW) which can cause symptoms of dyspnea. Lung ultrasound (LUS) is a highly feasible, non-invasive procedure that is extremely sensitive for detecting EVLW. The sonographic signature of EVLW is a reverberation artifact called a "B-Line". The study will evaluate the etiology of sonographic B-Lines using invasive hemodynamic catheterization while simultaneously measuring the amount of EVLW present during exercise stress testing using transpulmonary thermodilution. The study aim is to demonstrate that the severity of EVLW, assessed by number of B-Lines, will correlate with LV filling pressures. In addition, the study will test the hypothesis that patients demonstrating dynamic increases in sonographic B-Lines with exercise will also display more severe symptoms of dyspnea, altered ventilatory mechanics (higher ratio of minute ventilation to carbon dioxide production (VE/VCO2)), and reduced aerobic capacity (lower peak oxygen consumption (VO2)).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing clinical invasive hemodynamic stress test | Experimental | Subjects scheduled for standard-of-care, clinically indicated, invasive hemodynamic stress test will undergo lung ultrasound and assessment of extravascular lung water by pulmonary thermodilution technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung ultrasound | Diagnostic Test | Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the Number of Lung Ultrasound B-Lines With Intra-cardiac Filling Pressures | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements of intra-cardiac filling pressures . | Lung ultrasound imaging for B-Lines and assessment of intracardiac hemodynamics will be performed during the scheduled invasive stress test (initial visit, day #1). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the Number of Lung Ultrasound B-Lines With Ventilatory Mechanics. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements ventilatory mechanic parameters measured using expiratory gas. | Lung ultrasound imaging and assessment of ventilatory mechanics (using analysis of expired gas) will be performed during the scheduled invasive stress test (initial visit, day #1). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barry Borlaug, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Undergoing Clinical Invasive Hemodynamic Stress Test | Subjects scheduled for standard-of-care, clinically indicated, invasive hemodynamic stress test will undergo lung ultrasound and assessment of extravascular lung water by pulmonary thermodilution technique. Lung ultrasound: Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Undergoing Clinical Invasive Hemodynamic Stress Test | Subjects scheduled for standard-of-care, clinically indicated, invasive hemodynamic stress test will undergo lung ultrasound and assessment of extravascular lung water by pulmonary thermodilution technique. Lung ultrasound: Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation of the Number of Lung Ultrasound B-Lines With Intra-cardiac Filling Pressures | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements of intra-cardiac filling pressures . | Study terminated due to funding and time constraints. Data not collected or analyzed. | Posted | Lung ultrasound imaging for B-Lines and assessment of intracardiac hemodynamics will be performed during the scheduled invasive stress test (initial visit, day #1). |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Undergoing Clinical Invasive Hemodynamic Stress Test | Subjects scheduled for standard-of-care, clinically indicated, invasive hemodynamic stress test will undergo lung ultrasound and assessment of extravascular lung water by pulmonary thermodilution technique. Lung ultrasound: Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brandon M. Wiley | Mayo Clinic | 507-255-1051 | Wiley.Brandon@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2021 | May 9, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
All patients undergoing a clinically indicated invasive cardiac hemodynamic exercise test will be eligible for enrollment into the study.
Not provided
Not provided
Not provided
Not provided
|
|
| Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Measurement of Extravascular Lung Water. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements extravascular lung water using transpulmonary thermodilution. | Lung ultrasound imaging and assessment of the amount of extravascular lung water using transpulmonary thermodilution will be performed during the scheduled invasive stress test (initial visit, day #1). |
| Lung Ultrasound B-Lines Developed During Invasive Stress and the Calculated Amount of Extravascular Lung Water Will be Correlated With Changes in the Levels of Serum Protein, Hemoglobin and Brain Natriuretic Peptide Levels. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements extravascular lung water using transpulmonary thermodilution. In addition, serum levels of hemoglobin, protein and brain natriuretic peptide will be collected, synchronously, during the stress test. | Serum biomarkers, lung ultrasound and assessment of extravascular lung water will be performed during the scheduled invasive stress test (initial visit, day #1). |
| Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Clinical Outcomes. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with patient clinical outcomes defined as a composite outcome of hospital readmission, non-fatal myocardial infarction, or cardiovascular death. | 24 months post-stress test. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Correlation of the Number of Lung Ultrasound B-Lines With Ventilatory Mechanics. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements ventilatory mechanic parameters measured using expiratory gas. | Study terminated due to funding and time constraints. Data not collected or analyzed. | Posted | Lung ultrasound imaging and assessment of ventilatory mechanics (using analysis of expired gas) will be performed during the scheduled invasive stress test (initial visit, day #1). |
|
|
| Secondary | Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Measurement of Extravascular Lung Water. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements extravascular lung water using transpulmonary thermodilution. | Study terminated due to funding and time constraints. Data not collected or analyzed. | Posted | Lung ultrasound imaging and assessment of the amount of extravascular lung water using transpulmonary thermodilution will be performed during the scheduled invasive stress test (initial visit, day #1). |
|
|
| Secondary | Lung Ultrasound B-Lines Developed During Invasive Stress and the Calculated Amount of Extravascular Lung Water Will be Correlated With Changes in the Levels of Serum Protein, Hemoglobin and Brain Natriuretic Peptide Levels. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements extravascular lung water using transpulmonary thermodilution. In addition, serum levels of hemoglobin, protein and brain natriuretic peptide will be collected, synchronously, during the stress test. | Study terminated due to funding and time constraints. Data not collected or analyzed. | Posted | Serum biomarkers, lung ultrasound and assessment of extravascular lung water will be performed during the scheduled invasive stress test (initial visit, day #1). |
|
|
| Secondary | Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Clinical Outcomes. | Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with patient clinical outcomes defined as a composite outcome of hospital readmission, non-fatal myocardial infarction, or cardiovascular death. | Study terminated due to funding and time constraints. Data not collected or analyzed. | Posted | 24 months post-stress test. |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |