- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02241525
CT for Pulmonary Thromboembolic Disease (CT for PE)
Individually Optimized Uniform Contrast Enhancement in CT Angiography for the Diagnosis of Pulmonary Thromboembolic Disease
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients 18 years old or older
- Patients who have been recommended for CTPA scan for the diagnosis of pulmonary; thromboembolic disease (PE) in the Department of Diagnostic Radiology and Nuclear Medicine at the University of Maryland-Patients whose body mass index (BMI) is greater than 30 kg/m2.
- Patients whose body mass index (BMI) is greater than 30 kg/m2
- Patients who signed the University of Maryland Medical Center Consent for Intravenous Contrast Administration
Exclusion Criteria:
- Pregnant or breast-feeding women; Female participants of childbearing age (10 - 60 years) will be screened for their pregnancy status prior to study registration, by following the Department of Diagnostic Radiology and Nuclear Medicine CLINICAL STANDARD Procedure DI-AOP-003 "Pregnancy Screening Documentation"; - Patients with decreased renal function34-36. This is evaluated by blood work checked within 30 days prior to the CTPA scan with contrast. Patients cannot receive contrast if their BUN index is not within [7-20] or creatinine is not within [0.5 - 1.4] mg/dL
- Patients with decreased renal function34-36. This is evaluated by blood work checked within current admission for inpatients or within 30 days for outpatients prior to the CTPA scan with contrast. Patients cannot receive contrast if their serum creatinine level exceeds 2.0 mg/dL
- Patients with known moderate or severe allergic reactions to contrast, including but not limited to: shortness of breath, a change in baseline vital signs, such as a change in blood pressure, tachycardia, increased respirations that can progress to major respiratory distress, laryngeal edema, bronchospasm, arrhythmias, convulsions, and cardiopulmonary arrest.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Prospective
Twenty patients will be enrolled and scanned with the RESEARCH procedures
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Retrospective
Patients with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan
Tidsramme: 1 year
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The primary endpoint is to study the feasibility( bi-phasic vs. singular pahse contrast injection (by comparison analysis)) of individually optimized bi-phasic contrast injection for CTPA scan.
|
1 year
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Efficacy of PE diagnosis with CTPA imaging
Tidsramme: 1 year
|
To quantify the efficacy (by comparison analysis) of PE diagnosis of this new contrast injection protocol in terms of reduced frequency of non-diagnostic CTPA image vs. standard of care procedures.
|
1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
# of patients who receive contrast enhancement and CNR of CTPA scans
Tidsramme: 1 year
|
A secondary endpoint is to quantitatively evaluate (by comparison analysis) the contrast enhancement and CNR of CTPA scans. Twenty patients (20) will be enrolled and scanned with the RESEARCH procedures. Another twenty retrospective patients (20) with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan and enrolled on retrospective protocol: HP-00056512 "Individually optimized uniform contrast enhancement in CT angiography for the diagnosis of pulmonarythromboembolic disease - A simulation study". |
1 year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Wei Lu, PhD, Univerysity of Maryland Baltimore
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HP-00063432
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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