- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02620397
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.
After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94110
- San Francisco General Hospital & Trauma Center
-
-
Florida
-
Gainesville, Florida, Forente stater, 32608
- University of Florida
-
-
Idaho
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Idaho Falls, Idaho, Forente stater, 83404
- Eastern Idaho Regional Medical Center
-
-
Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville
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Louisville, Kentucky, Forente stater, 40202
- Kentucky Clinical Trials Laboratories
-
-
Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland
-
-
Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
- Hennepin County Medical Ctr
-
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Sunrise Hospital
-
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North Carolina
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Charlotte, North Carolina, Forente stater, 28293
- Carolinas Medical Center
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Greenville, North Carolina, Forente stater, 27834
- East Carolina University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson Univeristy
-
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University
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Texas
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Houston, Texas, Forente stater, 77030
- Ben Taub
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- The informed consent must be signed by the subject, or the subject's legal authorized representative.
- 21 years of age or greater at the time of enrollment
- Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm.
Exclusion Criteria:
- Informed consent form not signed
- Age <21 years
- Known pregnancy -
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinical performance of the Meritas Troponin I test
Tidsramme: 24-hours
|
Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)
|
24-hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).
Tidsramme: 1 year
|
Kaplan-Meier survival curves and risk ratios.
A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Jim Rock, Trinity Biotech
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP7001_5ACS
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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