Clinical trial NCT02241525: CT for Pulmonary Thromboembolic Disease
Official title: Individually Optimized Uniform Contrast Enhancement in CT Angiography for the Diagnosis of Pulmonary Thromboembolic Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Embolism
Keywords: Pulmonary
Thromboembolic
Lung
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients for a diagnosis of PE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of patients with individually optimized bi-phasic contrast injection for CTPA scan
timeFrame: 1 year
measure: Efficacy of PE diagnosis with CTPA imaging
timeFrame: 1 year
Secondary outcomes:
measure: # of patients who receive contrast enhancement and CNR of CTPA scans
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: Univerysity of Maryland Baltimore
name: Wei Lu, PhD
role: PRINCIPAL_INVESTIGATOR
References: