Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli
Primary Purpose
Multiple Pulmonary Emboli
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Dose IV Contrast
Siemens Sensation 64-MDCT scanner.
Visipaque 320 non-ionic isoosmolar contrast agent
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Pulmonary Emboli focused on measuring Pulmonary Embolus, Radio Contrast Material, Computed Tomography
Eligibility Criteria
Inclusion Criteria:
- Patients referred for CT pulmonary angiogram to exclude pulmonary embolus
Exclusion Criteria:
- Class 3 or 4 Congestive Heart Failure
- Supraventricular tachycardia
- History of contrast allergy
- Unable to give informed consent
- Patients with serum creatinine >1.28 mg/dl without referring physician approval
Sites / Locations
- VALosAngeles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-Dose IV Contrast
Full-Dose IV Contrast
Arm Description
A single intravenous dose of 30 ml of Visipaque 320 non-ionic isoosmolar contrast agent will be given for each CT scan. The CT scan will be performed using a Siemens Sensation 64-MDCT scanner.
A single intravenous dose of 100ml of Visipaque 320 non-ionic isoosmolar contrast agent will be given for each CT scan. The CT scan will be performed using a Siemens Sensation 64-MDCT scanner.
Outcomes
Primary Outcome Measures
CT Image Quality Score
Secondary Outcome Measures
Full Information
NCT ID
NCT01935141
First Posted
August 21, 2013
Last Updated
November 6, 2016
Sponsor
VA Greater Los Angeles Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01935141
Brief Title
Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli
Official Title
Efficacy Of Low(30 Ml) Versus Full Dose (100 Ml)Contrast CT Pulmonary Angiography Performed On 64 Multi-Detector CT In Detecting Emboli
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Staffing difficulties to run project.
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique.
Detailed Description
Potential participants in the study will have been referred to the radiology section for a CTPA for a suspected pulmonary embolus. The radiologist will review the patient's record in CPRS, as is done routinely in this situation. Patients with class 3 or 4 CHF, supraventricular tachycardia, Serum Creatinine >1.5 mg/dl (>1.3 mg/dl female), history of contrast allergy, or unable to give informed consent will be excluded from both arms of the study. Patients with serum creatinine >1.28 mg/dl require referring physician approval. If the participant appears to qualify for the study then the study physician will contact the referring physician and inform him/her of the study. If the referring physician is agreeable then either the radiologist or the referring physician will approach the patient, either at the bedside or in the radiology clinic to determine if the patient is interested in participating in the study. If so, a study radiologist will begin the informed consent process. After informed consent is obtained the subject will be computer randomized to either the new low-dose or full-dose technique protocols. A total of 220 studies (110 per group) will be performed.
Multidetector CT Scan: All CT examinations will be performed on the Siemens Sensation 64-MDCT scanner. Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be used in all contrast examinations followed by a subsequent injection of normal saline. An informed written consent for the injection of IV contrast will be obtained prior to all CT examinations. Safe venous access will be obtained via either an antecubital vein or a central venous line. For low dose CT pulmonary angiograms, 30 ml of IV Radio Contrast Material (RCM) will be injected at a flow rate of 5 ml/second followed by an injection of 20 ml of normal saline at 5ml/second. The region of interest (ROI) will be the superior vena cava (SVC) at the approximate level of the aortic arch. The scan will be triggered to begin at 75 Hounsfield units (HU). For Full dose CT pulmonary angiograms, 100 ml of IV RCM will be injected at a flow rate of 5ml/sec. The ROI will be the main pulmonary artery. The scan will be triggered at 120 HU. One mm contiguous axial spiral scans will be obtained from the apex of the lung through the adrenals. Reformatted 1.5 mm axial, 3 mm axial, 1.5 mm coronal and sagittal images will be obtained. All images will be uploaded to the AGFA Picture Archiving Communication System (PACS) workstation for interpretation. The costs of all CT scans and RCM will be covered by the Department of Imaging as the majority of the studies are part of routine clinical care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Pulmonary Emboli
Keywords
Pulmonary Embolus, Radio Contrast Material, Computed Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Dose IV Contrast
Arm Type
Experimental
Arm Description
A single intravenous dose of 30 ml of Visipaque 320 non-ionic isoosmolar contrast agent will be given for each CT scan. The CT scan will be performed using a Siemens Sensation 64-MDCT scanner.
Arm Title
Full-Dose IV Contrast
Arm Type
Active Comparator
Arm Description
A single intravenous dose of 100ml of Visipaque 320 non-ionic isoosmolar contrast agent will be given for each CT scan. The CT scan will be performed using a Siemens Sensation 64-MDCT scanner.
Intervention Type
Procedure
Intervention Name(s)
Low-Dose IV Contrast
Other Intervention Name(s)
Visipaque, Iodixanol
Intervention Description
A single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan.
Intervention Type
Device
Intervention Name(s)
Siemens Sensation 64-MDCT scanner.
Intervention Description
The device will be used to perform CT Pulmonary Angiograms
Intervention Type
Drug
Intervention Name(s)
Visipaque 320 non-ionic isoosmolar contrast agent
Other Intervention Name(s)
Iodixanol
Intervention Description
Single Dose of Intravenous Iodixanol will be administered per CT scan.
Primary Outcome Measure Information:
Title
CT Image Quality Score
Time Frame
Within 4 weeks of the CT scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred for CT pulmonary angiogram to exclude pulmonary embolus
Exclusion Criteria:
Class 3 or 4 Congestive Heart Failure
Supraventricular tachycardia
History of contrast allergy
Unable to give informed consent
Patients with serum creatinine >1.28 mg/dl without referring physician approval
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce M. Barack, M.D.
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VALosAngeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli
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