Multiple Pulmonary EmboliNCT01935141
Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli
A study testing Low-Dose IV Contrast, Siemens Sensation 64-MDCT scanner. and Visipaque 320 non-ionic isoosmolar contrast agent in people with Multiple Pulmonary Emboli, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pulmonary Emboli
- What is being tested?
- Low-Dose IV Contrast, Siemens Sensation 64-MDCT scanner. and Visipaque 320 non-ionic isoosmolar contrast agent
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for CT pulmonary angiogram to exclude pulmonary embolus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Pulmonary Emboli
- Being tested
- Low-Dose IV Contrast, Siemens Sensation 64-MDCT scanner., Visipaque 320 non-ionic isoosmolar contrast agent
- Keywords
- Pulmonary Embolus, Radio Contrast Material, Computed Tomography
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose IV ContrastProcedure or surgery
Also called Visipaque, Iodixanol
A single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan.
Siemens Sensation 64-MDCT scanner.Device
The device will be used to perform CT Pulmonary Angiograms
Visipaque 320 non-ionic isoosmolar contrast agentDrug
Also called Iodixanol
Single Dose of Intravenous Iodixanol will be administered per CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose IV Contrast | Experimental | 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. Receives: Procedure: Low-Dose IV Contrast; Device: Siemens Sensation 64-MDCT scanner.; Drug: Visipaque 320 non-ionic isoosmolar contrast agent |
| Full-Dose IV Contrast | Active comparator | 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. Receives: Procedure: Low-Dose IV Contrast; Device: Siemens Sensation 64-MDCT scanner.; Drug: Visipaque 320 non-ionic isoosmolar contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT Image Quality Score
Measured: Within 4 weeks of the CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Staffing difficulties to run project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary EmboliStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Bruce Barack, VA Greater Los Angeles Healthcare System
- Investigators
- Bruce M. Barack, M.D., Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935141
- Sponsor's protocol ID
- 2012-101526
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2013
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01935141
- Acronym / sponsor ID
- 2012-101526
- Conditions
- Multiple Pulmonary Emboli
- Keywords
- Pulmonary Embolus, Radio Contrast Material, Computed Tomography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staffing difficulties to run project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose IV Contrast | Experimental | Procedure: Low-Dose IV Contrast, Device: Siemens Sensation 64-MDCT scanner., Drug: Visipaque 320 non-ionic isoosmolar contrast agentA 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. |
| Full-Dose IV Contrast | Active comparator | Procedure: Low-Dose IV Contrast, Device: Siemens Sensation 64-MDCT scanner., Drug: Visipaque 320 non-ionic isoosmolar contrast agentA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for CT pulmonary angiogram to exclude pulmonary embolus
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose IV ContrastAlso: Visipaque, IodixanolA single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan. | Procedure or surgery | Full-Dose IV Contrast, Low-Dose IV Contrast |
| Siemens Sensation 64-MDCT scanner.The device will be used to perform CT Pulmonary Angiograms | Device | Full-Dose IV Contrast, Low-Dose IV Contrast |
| Visipaque 320 non-ionic isoosmolar contrast agentAlso: IodixanolSingle Dose of Intravenous Iodixanol will be administered per CT scan. | Drug | Full-Dose IV Contrast, Low-Dose IV Contrast |
Primary outcome
CT Image Quality Score
Time frame: Within 4 weeks of the CT scan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
Related trials for Multiple Pulmonary Emboli
RecruitingPhase 4
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
Venous Thromboembolism, Venous Thromboses
Active, not recruitingObservational study
FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
Deep Venous Thrombosis, Pulmonary Embolism
RecruitingObservational study
Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
Pulmonary Embolism
Recruiting
Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
Lymphoma, Leukemia
Recruiting
Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Acute Pulmonary Embolism (PE), Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce M. Barack, M.D. principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose IV Contrast, Siemens Sensation 64-MDCT scanner. and Visipaque 320 non-ionic isoosmolar contrast agent in people with Multiple Pulmonary Emboli, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT Image Quality Score (time frame: Within 4 weeks of the CT scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.