CT for Pulmonary Thromboembolic Disease

Pulmonary Embolism Clinical Trial

— CT for PE  

Official title:

Individually Optimized Uniform Contrast Enhancement in CT Angiography for the Diagnosis of Pulmonary Thromboembolic Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02241525
• Other study ID #: HP-00063432
• Status: Terminated
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Examine the feasibility and efficacy of individually optimized uniform contrast enhancement in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.

Description:

Patient characteristics, qualitative image quality scores, and quantitative contrast enhancement and CNR will be described using mean values and standard deviations for continuous variables, and frequencies and percent for categorical variables. Difference between the two patient groups will be compared using Wilcoxon signed rank tests and chi-square statistics for continuous and categorical variables, respectively. All statistical tests will be performed at a significance level of 0.05.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan	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
Primary	Efficacy of PE diagnosis with CTPA imaging	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
Secondary	# of patients who receive contrast enhancement and CNR of CTPA scans	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