Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by VA Greater Los Angeles Healthcare System
Sponsor:
Information provided by (Responsible Party):
Bruce Barack, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT01935141
First received: August 21, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Multiple Pulmonary Emboli
Procedure: Low-Dose IV Contrast
Device: Siemens Sensation 64-MDCT scanner.
Drug: Visipaque 320 non-ionic isoosmolar contrast agent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • CT Image Quality Score [ Time Frame: Within 4 weeks of the CT scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Dose IV Contrast
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.
Procedure: Low-Dose IV Contrast
A single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan.
Other Names:
  • Visipaque
  • Iodixanol
Device: Siemens Sensation 64-MDCT scanner.
The device will be used to perform CT Pulmonary Angiograms
Drug: Visipaque 320 non-ionic isoosmolar contrast agent
Single Dose of Intravenous Iodixanol will be administered per CT scan.
Other Name: Iodixanol
Active Comparator: Full-Dose IV Contrast
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.
Procedure: Low-Dose IV Contrast
A single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan.
Other Names:
  • Visipaque
  • Iodixanol
Device: Siemens Sensation 64-MDCT scanner.
The device will be used to perform CT Pulmonary Angiograms
Drug: Visipaque 320 non-ionic isoosmolar contrast agent
Single Dose of Intravenous Iodixanol will be administered per CT scan.
Other Name: Iodixanol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935141

Contacts
Contact: Bruce M Barack, MD 310-478-3711 ext 41579 Bruce.Barack@va.gov

Locations
United States, California
VALosAngeles Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Elizabeth Corey, PhD    301-268-3080    Elizabeth.Corey@va.gov   
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
Principal Investigator: Bruce M. Barack, M.D. VA Greater Los Angeles Healthcare System
  More Information

No publications provided

Responsible Party: Bruce Barack, Staff Radiologist, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT01935141     History of Changes
Other Study ID Numbers: 2012-101526
Study First Received: August 21, 2013
Last Updated: August 29, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Greater Los Angeles Healthcare System:
Pulmonary Embolus
Radio Contrast Material
Computed Tomography

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014