Trial Outcomes & Findings for Assessmet of Patients With PAH Right Ventricular Volume (NCT NCT01557582)
NCT ID: NCT01557582
Last Updated: 2015-03-27
Results Overview
% Difference was measured for right ventricular EDV, ESV and EF.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
Right Ventrical Volume Comparison
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Right Ventrical Volume Comparison
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Operator error
|
2
|
Baseline Characteristics
Assessmet of Patients With PAH Right Ventricular Volume
Baseline characteristics by cohort
| Measure |
Right Ventrical Volume Comparison
n=101 Participants
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American/Nat. Alaska
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaii/Pac Island
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
65 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=5 Participants
|
|
WHO Functional Health Class
Functional Class I
|
7 participants
n=5 Participants
|
|
WHO Functional Health Class
Functional Class II
|
46 participants
n=5 Participants
|
|
WHO Functional Health Class
Functional Class III
|
48 participants
n=5 Participants
|
|
Etiology
CONNECTIVE TISSUE
|
39 participants
n=5 Participants
|
|
Etiology
PORTAL HYPERTENSION
|
2 participants
n=5 Participants
|
|
Etiology
Simple Congenital
|
6 participants
n=5 Participants
|
|
Etiology
Drug/Toxin
|
4 participants
n=5 Participants
|
|
Etiology
Idiopathic
|
46 participants
n=5 Participants
|
|
Etiology
HIV Infection
|
1 participants
n=5 Participants
|
|
Etiology
Heritable
|
2 participants
n=5 Participants
|
|
Etiology
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.Population: Only evaluable participants were analyzed
% Difference was measured for right ventricular EDV, ESV and EF.
Outcome measures
| Measure |
Right Ventrical Volume Comparison
n=75 Participants
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Observed Mean (Std Err) for % Difference Between VMS and MRI.
EDV
|
4.80 Percent difference
Standard Error 1.35
|
|
Observed Mean (Std Err) for % Difference Between VMS and MRI.
ESV
|
1.76 Percent difference
Standard Error 1.51
|
|
Observed Mean (Std Err) for % Difference Between VMS and MRI.
EF
|
2.03 Percent difference
Standard Error 0.66
|
SECONDARY outcome
Timeframe: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.Population: All evaluable subjects.
A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.
Outcome measures
| Measure |
Right Ventrical Volume Comparison
n=75 Participants
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Inter-Observer Variability
EDV Observer 2 vs. 1
|
12.99 Percent difference
Standard Deviation 10.59
|
|
Inter-Observer Variability
EDV Observer 3 vs. 1
|
18.41 Percent difference
Standard Deviation 16.45
|
|
Inter-Observer Variability
EDV Observer 3 vs. 2
|
18.49 Percent difference
Standard Deviation 15.05
|
|
Inter-Observer Variability
ESV Observer 2 vs. 1
|
10.13 Percent difference
Standard Deviation 8.60
|
|
Inter-Observer Variability
ESV Observer 3 vs. 1
|
15.10 Percent difference
Standard Deviation 13.90
|
|
Inter-Observer Variability
ESV Observer 3 vs. 2
|
14.38 Percent difference
Standard Deviation 12.53
|
|
Inter-Observer Variability
EF Observer 2 vs. 1
|
5.83 Percent difference
Standard Deviation 4.51
|
|
Inter-Observer Variability
EF Observer 3 vs. 1
|
6.12 Percent difference
Standard Deviation 5.46
|
|
Inter-Observer Variability
EF Observer 3 vs. 2
|
6.83 Percent difference
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
Outcome measures
| Measure |
Right Ventrical Volume Comparison
n=35 Participants
Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.
Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images.
|
|---|---|
|
Intra-Observer Variability
EDV Observer 1
|
1.41 Percent difference
Standard Deviation 6.40
|
|
Intra-Observer Variability
EDV Observer 2
|
2.43 Percent difference
Standard Deviation 11.92
|
|
Intra-Observer Variability
EDV Observer 3
|
3.48 Percent difference
Standard Deviation 20.51
|
|
Intra-Observer Variability
ESV Observer 1
|
4.01 Percent difference
Standard Deviation 4.99
|
|
Intra-Observer Variability
ESV Observer 2
|
1.66 Percent difference
Standard Deviation 10.32
|
|
Intra-Observer Variability
ESV Observer 3
|
10.72 Percent difference
Standard Deviation 20.38
|
|
Intra-Observer Variability
EF Observer 1
|
-1.33 Percent difference
Standard Deviation 2.00
|
|
Intra-Observer Variability
EF Observer 2
|
0.15 Percent difference
Standard Deviation 4.49
|
|
Intra-Observer Variability
EF Observer 3
|
-3.02 Percent difference
Standard Deviation 8.81
|
Adverse Events
Right Ventrical Volume Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jim bodtke, Vice President Clinical Affairs and Development
VentriPoint, Inc.
Phone: 206-283-0221
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60