CADence Performance as a Rule-Out Modality in Long Beach Veterans Administration Heart Catheterization Lab Patients (SOLDIER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03116438|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases||Device: CADence||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CADence Performance as a Rule-Out Modality in Long Beach Veterans Administration Heart Catheterization Lab Patients|
|Estimated Study Start Date :||June 16, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: CADence3 Device
If you agree to participate in this study, you will be asked to allow recording of sounds from four (4) sites on your chest using the CADence device. The CADence test will take approximately 15 minutes to complete. This is a single-arm study.
The CADence device collects acoustic (sound) data from locations on the chest for the purpose of identifying coronary artery turbulence, which may be indicative of coronary artery disease. The test will take approximately 15 minutes to complete. There are no follow-up procedures associated with the study.
Other Name: CADence3
- Percent Agreement [ Time Frame: six months ]Percent positive agreement and percent negative agreement of CADence device under normal use conditions as compared to coronary angiogram.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116438
|Contact: Jacqueline A Nguyen, BA||562-826-8000 ext firstname.lastname@example.org|
|Contact: Daniel Amador||562-826-8000 ext email@example.com|
|Principal Investigator:||Arnold H Seto, MD,MPA||LBVAHS|