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

Clinical Evaluation of the BinaxNOW® COVID-19 Antigen (Ag) Card.

Date Added
May 21st, 2020
PRO Number
Pro00100154
Researcher
Gary Headden

List of Studies


Keywords
Coronavirus
Summary

The research study is been conducted in people who may or may not have symptoms that could be due to coronavirus 2019-nCoV. The reason for this study is to collect nasal swab samples from people suspected of having the 2019-nCoV (coronavirus) to help make new tests for detecting this virus, and/or make current tests better.

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

VITROS® Immunodiagnostic Products hs Troponin I US Sample Collection Protocol

Date Added
May 8th, 2018
PRO Number
Pro00076320
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Heart, Non-interventional
Summary

Roughly 8-10 million patients complaining of chest pain come to an Emergency Department (ED) annually in the United States. Quickly determining if you are having a heart attack is critical for improving your chances of survival. Cardiac troponin is a protein that is used as a biomarker (biological marker) to indicate damage to the heart muscle. Cardiac troponin lab tests that are currently used in the United States do not have the ability to detect low levels of troponin. There are more sensitive troponin tests that are primarily used outside the US, that are able to detect lower levels of cardiac troponin within 90-180 minutes instead of 5 or 6 hours. This allows for the early identification of individuals at a higher risk for heart damage and these patients benefit from early diagnosis and treatment. Delaying the treatment of a heart attack increases the chance of dying or being permanently disabled. This study will collect blood samples from people coming to the Emergency Department complaining of chest pain in order to measure this troponin lab test's ability to accurately detect troponin levels.

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



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