A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01076296
• Collaborator: Oregon Health and Science University (Other)
• Enrollment: 1,000
• Location: 1
• Duration (Months): 28.9
• Patients Per Site Per Month: 34.5

Study Details

Study Description

Brief Summary

This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Dysfunction; Right Ventricular Dysfunction; Pulmonary Hypertension; Heart Valve Diseases

Detailed Description

The study requires 2 visits to OHSU.

At the first visit a cardiac physical exam will be done by a cardiologist.

At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Outcome Measures

Primary Outcome Measures

1. Percentage of Correct Diagnosis [2 years]

   A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study

• New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care

Exclusion Criteria:

• Pregnant

• less than 18 years of age.

• unwilling to provide informed Consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• GE Healthcare
• Oregon Health and Science University

Investigators

• Principal Investigator: Sanjiv Kaul, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01076296
• Other Study ID Numbers: OHSU_Vscan_02
• First Posted: Feb 26, 2010
• Last Update Posted: Mar 7, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Hypertension, Pulmonary; Ventricular Dysfunction; Ventricular Dysfunction, Left; Heart Valve Diseases; Ventricular Dysfunction, Right

Study Results

Participant Flow

Arm/Group Title	Abnormal Left Ventricle Function	Normal Left Ventricle Function	Abnormal Right Ventricle Function	Normal Right Ventricle Function	Pulmonary Hypertension	No Pulmonary Hypertension	Heart Valve Disease	No Heart Valve Disease
Arm/Group Description	Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.	Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.	Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.	Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.	Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.	Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.	Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.	Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
Period Title: Overall Study
STARTED	54	196	51	199	59	191	51	199
COMPLETED	54	196	51	199	59	191	51	199
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Total for All Groups Assessed
Arm/Group Description	Subjects assessed for LV function using both VScan and a clinical examination.
Overall Participants	1000
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (15.4)
Sex: Female, Male (Count of Participants)
Female	656 65.6%
Male	344 34.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Correct Diagnosis
Description	A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abnormal Left Ventricle Function	Normal Left Ventricle Function	Abnormal Right Ventricle Function	Normal Right Ventricle Function	Pulmonary Hypertension	No Pulmonary Hypertension	Heart Valve Disease	No Heart Valve Disease
Arm/Group Description	Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.	Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.	Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.	Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.	Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.	Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.	Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.	Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
Measure Participants	54	196	51	199	59	191	51	199
Number (95% Confidence Interval) [percentage of correct diagnosis]	61	31	47	6	10	3	39	4

Adverse Events

Arm/Group Title	Abnormal Left Ventricle Function		Normal Left Ventricle Function		Abnormal Right Ventricle Function		Normal Right Ventricle Function		Pulmonary Hypertension		No Pulmonary Hypertension		Heart Valve Disease		No Heart Valve Disease
Arm/Group Description	Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.		Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.		Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.		Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.		Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.		Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.		Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.		Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
All Cause Mortality
	Abnormal Left Ventricle Function		Normal Left Ventricle Function		Abnormal Right Ventricle Function		Normal Right Ventricle Function		Pulmonary Hypertension		No Pulmonary Hypertension		Heart Valve Disease		No Heart Valve Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Abnormal Left Ventricle Function		Normal Left Ventricle Function		Abnormal Right Ventricle Function		Normal Right Ventricle Function		Pulmonary Hypertension		No Pulmonary Hypertension		Heart Valve Disease		No Heart Valve Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/196 (0%)		0/51 (0%)		0/199 (0%)		0/59 (0%)		0/191 (0%)		0/51 (0%)		0/199 (0%)
Other (Not Including Serious) Adverse Events
	Abnormal Left Ventricle Function		Normal Left Ventricle Function		Abnormal Right Ventricle Function		Normal Right Ventricle Function		Pulmonary Hypertension		No Pulmonary Hypertension		Heart Valve Disease		No Heart Valve Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/196 (0%)		0/51 (0%)		0/199 (0%)		0/59 (0%)		0/191 (0%)		0/51 (0%)		0/199 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.