QuidelOrtho, Inc. / "The 99th Percentile Upper Reference Limit for the TriageTrue High Sensitivity Troponin Test"

Date Added
February 28th, 2024
PRO Number
Pro00134743
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

This is a study designed to determine the 99th percentile upper reference limit (URL) for the Quidel
TriageTrue® hs-Tnl Test (TriageTrue) in whole blood and plasma.
The study will enroll apparently healthy adults. Potential subjects will be pre-screened for
eligibility using a questionnaire to assess comorbidities, chronic conditions, and medication use.
Those with comorbidities or chronic conditions that potentially affect the heart will not be eligible,
nor will those who are prescribed medications related to cardiovascular disease or risk factors.

Institution
MUSC
Recruitment Contact
Alexa Rubenstein
18436931860
rubenste@musc.edu

Informed Choice Intervention for Colorectal Cancer Screening: COMPASS

Date Added
September 14th, 2023
PRO Number
Pro00127491
Researcher
Gary Headden

List of Studies


Keywords
Cancer
Summary

The purpose of this research study is to see the impact of a study video on CRC screening rates and adherence.

Approximately 5,280 subjects will participate in this study at roughly 40 sites.

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

InSep in the Diagnosis and Prognosis of Emergency Department Patients with Suspected Infection and Suspected Sepsis (SEPSIS-SHEILD)"

Date Added
January 24th, 2023
PRO Number
Pro00121117
Researcher
Gary Headden

List of Studies


Keywords
Blood Disorders
Summary

Researchers want to find out more about how to manage and treat suspected infections and sepsis. Sepsis is a life-threatening condition in which your body is fighting a severe infection.

This study is a collection of health information, blood samples and possibly a nose swab. The samples collected will depend on your doctor's recommendation.

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

Reference Range and Clinical Performance Evaluation of Elecsys IL-6 Assay in Neonatal Sepsis (US); Collection Study.

Date Added
June 22nd, 2022
PRO Number
Pro00119546
Researcher
Gary Headden

List of Studies


Keywords
Autoimmune disease
Summary

The study is an experimental laboratory test (Interleukin-6, abbreviated IL-6) for infection in your blood, called IL-6 Neonates_US. An IL-6 test is a laboratory test that has not been approved by the regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in your country. The results from experimental laboratory test used in this study will not be used to make a diagnosis or guide therapy.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Roche Diagnostics Solutions / "Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects with Symptoms of Acute Coronary Syndrome – PERFORM-TSIX Study"

Date Added
May 31st, 2022
PRO Number
Pro00119237
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The name of the study is PERFORM-TSIX. An investigational diagnostic test is a new diagnostic test, in this case a blood test.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Roche Diagnostics Solutions / "Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects with Symptoms of Acute Coronary Syndrome – PERFORM-TSIX Study"

Date Added
May 31st, 2022
PRO Number
Pro00119237
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The name of the study is PERFORM-TSIX. An investigational diagnostic test is a new diagnostic test, in this case a blood test.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Clinical Evaluation of the i-STAT hs-TnI Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Date Added
August 3rd, 2021
PRO Number
Pro00110711
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.

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

Clinical Evaluation of the i-STAT hs-TnI Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Date Added
August 3rd, 2021
PRO Number
Pro00110711
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu



-- OR --