Trial Outcomes & Findings for Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing (NCT NCT04019613)
NCT ID: NCT04019613
Last Updated: 2022-07-20
Results Overview
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 .
TERMINATED
NA
4 participants
Lung ultrasound imaging for B-Lines and assessment of intracardiac hemodynamics will be performed during the scheduled invasive stress test (initial visit, day #1).
2022-07-20
Participant Flow
Participant milestones
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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.
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing
Baseline characteristics by cohort
| Measure |
Subjects Undergoing Clinical Invasive Hemodynamic Stress Test
n=4 Participants
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.
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Age, Continuous
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60.75 years
STANDARD_DEVIATION 17.6 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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4 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Lung ultrasound imaging for B-Lines and assessment of intracardiac hemodynamics will be performed during the scheduled invasive stress test (initial visit, day #1).Population: Study terminated due to funding and time constraints. Data not collected or analyzed.
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 .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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).Population: Study terminated due to funding and time constraints. Data not collected or analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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).Population: Study terminated due to funding and time constraints. Data not collected or analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Serum biomarkers, lung ultrasound and assessment of extravascular lung water will be performed during the scheduled invasive stress test (initial visit, day #1).Population: Study terminated due to funding and time constraints. Data not collected or analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-stress test.Population: Study terminated due to funding and time constraints. Data not collected or analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Subjects Undergoing Clinical Invasive Hemodynamic Stress Test
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place