Low-dose CT Angiography in the Detection of Acute Pulmonary Embolism: Validation in an Obese Population

NCT04018014 | Unknown

• 1 other identifier: 2019 CASSAGNES
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Pulmonary Embolism; Obesity; CT Scanner

Keywords

Pulmonary embolism; Obesity; CT scanner; Iterative reconstructions

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Secondary Outcomes (1)

• Scale of confidence (Likert)

  Day 0

Study Arms (2)

< 30 kg/m2

patients with BMI \< 30/kg/m2

Other: CT angiography

>30 kg/m2

patients with BMI \> 30 kg/m2

Other: CT angiography

Interventions

CT angiography OTHER

CT angiography in detection of pulmonary embolism

< 30 kg/m2; >30 kg/m2

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

Patients with suspicion of pulmonary embolism

You may qualify if:

• Patient \> 18
• Suspicion of pulmonary embolism
• Reparted in 2 groups :
• \< 30 kg/m2
• \> 30 kg/m2

You may not qualify if:

• Allergy to iodine contrast media
• Renal impairment with renal creatinine clearance \< 30 mL/min
• Pregnancy
• Refusal to participate in the study

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 25459197 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Obesity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucie CASSAGNES, MD-PHD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: March 21, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-07

Locations

FR (1)