VITROS Immunodiagnostic Products NT-proBNP II
Study Details
Study Description
Brief Summary
Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
A prospective clinical sample collection and NT-proBNP testing will be conducted in two populations. Patients presenting to the Emergency Department (ED) and patients presenting to outpatient centers will be approached for enrollment.
Clinical and laboratory data will be collected to demonstrate product performance compared to adjudicated clinical diagnosis. Approximately 4300 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.
Sample collection and testing of clinical samples with the VITROS NT-proBNP II assay will be performed under two separate protocols.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ED Setting An acute HF population enrolled at EDs. Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay. |
Diagnostic Test: VITROS Immunodiagnostic Products
NT-proBNP II assay
|
| Outpatient Setting A non-acute population enrolled at outpatient centers.Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay. |
Diagnostic Test: VITROS Immunodiagnostic Products
NT-proBNP II assay
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity of the VITROS NT-proBNP II assay [Single blood draw upon study entry 1day]
Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.
Secondary Outcome Measures
- Heart Failure Severity Assessment [Single blood draw upon study entry 1 day]
Demonstrate that the VITROS NT-proBNP II assay may be used for assessment of heart failure severity.
Eligibility Criteria
Criteria
Acute HF Population (ED setting):
Inclusion Criteria:
-
Subjects must have suspicion of HF and acute symptoms at presentation.
-
Subjects must be at least 22 years of age.
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Subjects must be willing and able to provide informed consent.
Exclusion Criteria:
-
Acute symptoms clearly not secondary to HF.
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Subjects with renal disease on dialysis.
-
Subjects unable to comply with the study requirements.
Population with suspicion of HF (Outpatient Setting):
Inclusion Criteria:
-
Subjects must be at least 22 years of age.
-
Subjects must be willing and able to provide informed consent.
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Subjects who present to outpatient centers with suspicion HF.
Exclusion Criteria:
-
Symptoms clearly not secondary to HF.
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Subjects with renal disease on dialysis.
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Subjects unable to comply with the study requirements.
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Subjects previously diagnosed with heart failure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Drug Research Analysis Corp | Montgomery | Alabama | United States | 36106 |
| 2 | University of Arizona Banner - University Medical Center South Campus | Tucson | Arizona | United States | 85724 |
| 3 | Westside Medical Associates of Los Angeles | Beverly Hills | California | United States | 90211 |
| 4 | University of California Davis Health | Sacramento | California | United States | 95817 |
| 5 | University of California San Diego Health | San Diego | California | United States | 92093 |
| 6 | Northwestern University | Evanston | Illinois | United States | 60208 |
| 7 | Indiana University Health Hospital (Eskenazi & Methodist) | Indianapolis | Indiana | United States | 46202 |
| 8 | Southern Clinical Research | Zachary | Louisiana | United States | 70791 |
| 9 | University of Maryland (Baltimore & St. Joseph) | Baltimore | Maryland | United States | 21201 |
| 10 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 11 | Wayne State University (Harper) | Detroit | Michigan | United States | 48201 |
| 12 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 13 | William Beaumont Hospital (Royal Oak & Troy) | Royal Oak | Michigan | United States | 48073 |
| 14 | Clinical Research of South Nevada | Las Vegas | Nevada | United States | 89121 |
| 15 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
| 16 | Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System) | Charlotte | North Carolina | United States | 28203 |
| 17 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 18 | University of Cincinnati Physicians Company | Cincinnati | Ohio | United States | 45229 |
| 19 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 20 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 21 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 22 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 23 | Baylor College of Medicine (Ben Taub) | Houston | Texas | United States | 77030 |
| 24 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 25 | INOVA Healthcare Services | Falls Church | Virginia | United States | 22042 |
Sponsors and Collaborators
- Ortho-Clinical Diagnostics, Inc.
Investigators
- Principal Investigator: Robert Christenson, PhD, University of Maryland, College Park
Study Documents (Full-Text)
None provided.More Information
Publications
- Darbar D, Davidson NC, Gillespie N, Choy AM, Lang CC, Shyr Y, McNeill GP, Pringle TH, Struthers AD. Diagnostic value of B-type natriuretic peptide concentrations in patients with acute myocardial infarction. Am J Cardiol. 1996 Aug 1;78(3):284-7.
- McDonagh TA, Robb SD, Murdoch DR, Morton JJ, Ford I, Morrison CE, Tunstall-Pedoe H, McMurray JJ, Dargie HJ. Biochemical detection of left-ventricular systolic dysfunction. Lancet. 1998 Jan 3;351(9095):9-13.
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.
- Richards AM, Nicholls MG, Yandle TG, Frampton C, Espiner EA, Turner JG, Buttimore RC, Lainchbury JG, Elliott JM, Ikram H, Crozier IG, Smyth DW. Plasma N-terminal pro-brain natriuretic peptide and adrenomedullin: new neurohormonal predictors of left ventricular function and prognosis after myocardial infarction. Circulation. 1998 May 19;97(19):1921-9.
- Valli N, Gobinet A, Bordenave L. Review of 10 years of the clinical use of brain natriuretic peptide in cardiology. J Lab Clin Med. 1999 Nov;134(5):437-44. Review.
- 16-001