Pulmonary EmbolismNCT04018014
Low-dose CT Angiography in the Detection of Acute Pulmonary Embolism: Validation in an Obese Population
An observational study of Pulmonary Embolism and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Pulmonary embolism is a common pathology in the general population, whose suspicion is based on the clinical and dosage of D-dimers in particular. The key examination for the diagnosis of pulmonary embolism is chest CT angiography (negative predictive value of 98%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Obesity, CT Scanner
- What is being tested?
- CT angiography
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2019to Sep 2019
- Phase
- Observational
- 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
Study population: Patients with suspicion of pulmonary embolism
Who may be able to join
- Patient > 18
- Suspicion of pulmonary embolism
- Reparted in 2 groups :
- < 30 kg/m2
- > 30 kg/m2
Who cannot join
- Allergy to iodine contrast media
- Renal impairment with renal creatinine clearance < 30 mL/min
- Pregnancy
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Lucie CASSAGNES, MD-PHD
About this study
Pulmonary embolism is a common pathology in the general population, whose suspicion is based on the clinical and dosage of D-dimers in particular.
The key examination for the diagnosis of pulmonary embolism is chest CT angiography (negative predictive value of 98%).
Read more
The evolution of machines in recent years allows a reduction of possible kilovoltage up to 80 kV, different computer algorithms (iterative reconstructions) to reconstruct the images and thus reduce the irradiation dose with equal image quality (Evaluation of dose CT and adaptive statistical reconstruction with the same group of patients, Qi et al, 2012; Impact of iterative reconstruction on the diagnosis of acute pulmonary embolism (PE) on reduced-dose chest CT angiograms, Pontana et al , 2015) in patient populations with a weight of less than 100 kilos.
However, obesity is a risk factor for pulmonary embolism and the obese population is increasing, thus requiring optimal management regarding irradiation.
Few studies have evaluated the quality of low dose CT angiography in obese patients. One study showed the possibility of performing low-dose thoracic CT angiography (100 kV) in patients up to 125 kg, without loss of subjective quality (but with an impact on objective quality), without the use of current iterative reconstruction techniques (Diagnostic confidence and image quality of CT pulmonary angiography at 100 kVp in overweight and obese patients, Megyeri et al, 2015).
The study seek to prove that in the obese patient, with a low dose examination (voltage of the tube at 100 kV) and the current iterative reconstructions, the thoracic angioscanner is not less efficient than in the non obese patient, that the qualities objective and subjective analyzes are maintained.
The main purpose is to evaluate and compare thoracic CT angiography with weight and BMI, with identical CT parameters (same voltage, computer reconstruction techniques and same contrast injection protocol), by evaluating the objective and subjective diagnostic quality of the opacification of the pulmonary arteries.
Read the detailed description
The study is monocentric, realised in University Hospital of Clermont-Ferrand, France, using the CT GE Revolution dedicated to the emergency service.
For each patient with suspicion of pulmonary embolism, regarding the inclusion and exclusion criteria (explained later), investigators realise the same protocol.
Patients are divided into 2 groups of weight : <30 kg/m2, > 30 kg/m2. There is no change in the management of patients, who benefit from an angioscan for pulmonary embolism, with an optimized protocol for patients under 100 kg and validated by the literature (Megyeri et al. , 2015) for patients over 100 kilos, with no loss of diagnostic chance and with an improvement over the irradiation compared to the usual protocols used (over-irradiation in the obese, up to 140 kV).
Concerning the CT protocol, a voltage of 100 kV is applied (irradiation 40% lower than a 120 kV test), with a modulation of the intensity of the current according to the Z axis and use of different levels of iterative reconstructions on images obtained to improve diagnostic performance.
Regarding the injection protocol, the same product with high concentration of iodine is injected to all patients (IOMERON 400), with a quantity relative to the weight of 1 mL / kg of patient weight, a maximum of 90 mL, a rate of 4 mL / s and rinsing with 30 mL of saline solution at 3 mL / sec
The session physician first carries out diagnostic work by searching for pulmonary embolism or an alternative diagnosis to explain the symptoms.
Secondly, the research work is carried out and the analyzed data with evaluation of the objective diagnostic quality, placing regions of circular interest or ROI (for regions of interest), in the pulmonary arteries, up to the sub-segmental branches.
The subjective quality is evaluated by two double-blind readers by a subjective quality scale.
The different elements are then compared according to two different groups of weights and BMIs. Intermediate statistical analyzes are planned for all 30 patients.
The study started on March 21st, for an estimated duration of 6 months initially. 65
- Conditions
- Pulmonary Embolism, Obesity, CT Scanner
- Being tested
- CT angiography
- Keywords
- Pulmonary embolism, Obesity, CT scanner, Iterative reconstructions
- Medical subject headings
- Pulmonary Embolism, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiographyOther
CT angiography in detection of pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| < 30 kg/m2 | patients with BMI < 30/kg/m2 Receives: Other: CT angiography | |
| >30 kg/m2 | patients with BMI > 30 kg/m2 Receives: Other: CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unit of hounsfield (UH) measurement in region of interest (ROI)
Unit of hounsfield (UH) measurement in region of interest (ROI) in the pulmonary artery, right and left branches, lobar branches, one segmental and subsegmental branch for each lobe, signal / noise ratio and contrast / noise for each ROI
Measured: Day 0
Secondary outcomes (1)
Scale of confidence (Likert)
Scale of confidence (Likert) on the subjective quality for each reader (2 readers) in 5 points : Total confidence, Good confidence, Neither good or bad confidence, Bad confidence, No confidence at all. Higher values represent a worse outcome.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start21 Mar 2019
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucie CASSAGNES, MD-PHD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018014
- Sponsor's protocol ID
- 2019 CASSAGNES
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Megyeri B, Christe A, Schindera ST, Horkay E, Sikula J, Cullmann JL, Kollar J, Heverhagen JT, Szucs-Farkas Z. Diagnostic confidence and image quality of CT pulmonary angiography at 100 kVp in overweight and obese patients. Clin Radiol. 2015 Jan;70(1):54-61. doi: 10.1016/j.crad.2014.09.014. Epub 2014 Oct 24.
PubMed 25459197
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose CT Angiography in the Detection of Acute Pulmonary Embolism: Validation in an Obese Population
- ClinicalTrials.gov ID
- NCT04018014
- Acronym / sponsor ID
- 2019 CASSAGNES
- Conditions
- Pulmonary Embolism, Obesity, CT Scanner
- Keywords
- Pulmonary embolism, Obesity, CT scanner, Iterative reconstructions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Jul 2019 (actual)
- 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.
Pulmonary embolism is a common pathology in the general population, whose suspicion is based on the clinical and dosage of D-dimers in particular.
The key examination for the diagnosis of pulmonary embolism is chest CT angiography (negative predictive value of 98%).
The evolution of machines in recent years allows a reduction of possible kilovoltage up to 80 kV, different computer algorithms (iterative reconstructions) to reconstruct the images and thus reduce the irradiation dose with equal image quality (Evaluation of dose CT and adaptive statistical reconstruction with the same group of patients, Qi et al, 2012; Impact of iterative reconstruction on the diagnosis of acute pulmonary embolism (PE) on reduced-dose chest CT angiograms, Pontana et al , 2015) in patient populations with a weight of less than 100 kilos.
However, obesity is a risk factor for pulmonary embolism and the obese population is increasing, thus requiring optimal management regarding irradiation.
Few studies have evaluated the quality of low dose CT angiography in obese patients. One study showed the possibility of performing low-dose thoracic CT angiography (100 kV) in patients up to 125 kg, without loss of subjective quality (but with an impact on objective quality), without the use of current iterative reconstruction techniques (Diagnostic confidence and image quality of CT pulmonary angiography at 100 kVp in overweight and obese patients, Megyeri et al, 2015).
The study seek to prove that in the obese patient, with a low dose examination (voltage of the tube at 100 kV) and the current iterative reconstructions, the thoracic angioscanner is not less efficient than in the non obese patient, that the qualities objective and subjective analyzes are maintained.
The main purpose is to evaluate and compare thoracic CT angiography with weight and BMI, with identical CT parameters (same voltage, computer reconstruction techniques and same contrast injection protocol), by evaluating the objective and subjective diagnostic quality of the opacification of the pulmonary arteries.
Detailed description
The study is monocentric, realised in University Hospital of Clermont-Ferrand, France, using the CT GE Revolution dedicated to the emergency service.
For each patient with suspicion of pulmonary embolism, regarding the inclusion and exclusion criteria (explained later), investigators realise the same protocol.
Patients are divided into 2 groups of weight : <30 kg/m2, > 30 kg/m2. There is no change in the management of patients, who benefit from an angioscan for pulmonary embolism, with an optimized protocol for patients under 100 kg and validated by the literature (Megyeri et al. , 2015) for patients over 100 kilos, with no loss of diagnostic chance and with an improvement over the irradiation compared to the usual protocols used (over-irradiation in the obese, up to 140 kV).
Concerning the CT protocol, a voltage of 100 kV is applied (irradiation 40% lower than a 120 kV test), with a modulation of the intensity of the current according to the Z axis and use of different levels of iterative reconstructions on images obtained to improve diagnostic performance.
Regarding the injection protocol, the same product with high concentration of iodine is injected to all patients (IOMERON 400), with a quantity relative to the weight of 1 mL / kg of patient weight, a maximum of 90 mL, a rate of 4 mL / s and rinsing with 30 mL of saline solution at 3 mL / sec
The session physician first carries out diagnostic work by searching for pulmonary embolism or an alternative diagnosis to explain the symptoms.
Secondly, the research work is carried out and the analyzed data with evaluation of the objective diagnostic quality, placing regions of circular interest or ROI (for regions of interest), in the pulmonary arteries, up to the sub-segmental branches.
The subjective quality is evaluated by two double-blind readers by a subjective quality scale.
The different elements are then compared according to two different groups of weights and BMIs. Intermediate statistical analyzes are planned for all 30 patients.
The study started on March 21st, for an estimated duration of 6 months initially. 65
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| < 30 kg/m2 | – | Other: CT angiographypatients with BMI < 30/kg/m2 |
| >30 kg/m2 | – | Other: CT angiographypatients with BMI > 30 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of pulmonary embolism
Key inclusion criteria (5 listed)
- Patient > 18
- Suspicion of pulmonary embolism
- Reparted in 2 groups :
- < 30 kg/m2
- > 30 kg/m2
Key exclusion criteria (4 listed)
- Allergy to iodine contrast media
- Renal impairment with renal creatinine clearance < 30 mL/min
- Pregnancy
- Refusal to participate in the study
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 |
|---|---|---|
| CT angiographyCT angiography in detection of pulmonary embolism | Other | < 30 kg/m2, >30 kg/m2 |
Primary outcome
Unit of hounsfield (UH) measurement in region of interest (ROI)
Time frame: Day 0
Unit of hounsfield (UH) measurement in region of interest (ROI) in the pulmonary artery, right and left branches, lobar branches, one segmental and subsegmental branch for each lobe, signal / noise ratio and contrast / noise for each ROI
1 secondary outcome
Scale of confidence (Likert)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Background: PubMed 25459197Megyeri B, Christe A, Schindera ST, Horkay E, Sikula J, Cullmann JL, Kollar J, Heverhagen JT, Szucs-Farkas Z. Diagnostic confidence and image quality of CT pulmonary angiography at 100 kVp in overweight and obese patients. Clin Radiol. 2015 Jan;70(1):54-61. doi: 10.1016/j.crad.2014.09.014. Epub 2014 Oct 24.
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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.
Lucie CASSAGNES, MD-PHD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Aug 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unit of hounsfield (UH) measurement in region of interest (ROI) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018014, which also lists 1 linked publication.
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 26 Aug 2019.