Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study Protocol

Date Added
February 11th, 2021
PRO Number
Pro00105432
Researcher
Gary Headden

List of Studies


Keywords
Heart
Summary

The purpose of this study is to use an investigational device called the Atellica® VTLi™ test system to test a substance in your blood called troponin that may help with the diagnosis of a heart attack

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

Collection of respiratory biological specimens by a health care professional (HCP) on participants who have or are suspected of having COVID-19 in the acute care setting.

Date Added
November 17th, 2020
PRO Number
Pro00105604
Researcher
Gary Headden

List of Studies


Keywords
Coronavirus
Summary

You are being asked to participate in a research study because you have been diagnosed or are suspected of having COVID-19 infection. The reason for this study is to collect nasal swabs from people diagnosed or suspected of having the 2019-nCoV (coronavirus) to use in the future to possibly help make new tests for detecting this virus, and/or make current tests better.
A company called Becton Dickinson & Company, the sponsor of the study, is paying for this study. Becton Dickinson & Company is also paying the study doctor to do this study.Approximately 2000 people will be enrolled across the US.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

Analytical Performance Evaluation of cobas pulse

Date Added
September 9th, 2020
PRO Number
Pro00102729
Researcher
Gary Headden

List of Studies


Keywords
Diabetes
Summary

The purpose of this study is to determine whether an accurate blood glucose (blood sugar level) result can be obtained from venous (vein), arterial (artery), capillary (finger) and neonatal heel stick blood samples by Point of Care users within both critically ill and non-critically ill study populations.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

PIVOTAL EVALUATION OF THE ACCESS NATRIURETIC PEPTIDE ASSAY(S) AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF SEVERITY OF ACUTE HEART FAILURE – EMERGENCY DEPARTMENT SUBJECT ENROLLMENT AND SPECIMEN COLLECTION

Date Added
February 17th, 2020
PRO Number
Pro00095805
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Heart
Summary

This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).

The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.

Institution
MUSC
Recruitment Contact
Annelise Kauffman
843-792-3576
kauffmaa@musc.edu



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