CT for Pulmonary Thromboembolic Disease

NCT02241525 | Terminated DMC

• 1 other identifier: HP-00063432
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary; Thromboembolic; Lung

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• # of patients who receive contrast enhancement and CNR of CTPA scans

  1 year

Study Arms (2)

Prospective

Twenty patients will be enrolled and scanned with the RESEARCH procedures

Retrospective

Patients with matching age and BMI will be selected from existing patients with a CLINICAL STANDARD of Care CTPA scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients for a diagnosis of PE

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wei Lu, PhD

  Univerysity of Maryland Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Investigator

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 16, 2014
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)