Clinical trial NCT04343196: Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction
Official title: Application of Digital Variance Angiography in Diagnostic Lower Limb Angiographiy for Radiation Exposure Reduction a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Artery Disease
Femoral Artery Stenosis
Femoral Artery Occlusion
Popliteal Stenosis
Iliac Artery Stenosis
Crural Artery Thrombosis
Limb Ischemia
Keywords: Radiation protection
X-ray angiography
Digital Variance Angiography
Digital Subtraction Angiography
Peripheral Arterial Disease
Kinepict
Image acquistion
Image quality
Radiation exposure
Lead sponsor: Kinepict Health Ltd.
Sponsor class: NETWORK
Collaborators: name: Semmelweis University Heart and Vascular Center
First posted: 2020-04-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All enrolled participants will undergo a diagnostic lower limb angiography, but the image acquisition protocol will be different. In the active comparator group a normal radiation dose will be used and the DSA images will be used for diagnosis whereas in the experimental group a low dose radiation will be applied (70% decrease compared tot he DSA protocol) and the DVA images will be used for diagnosis.
Primary purpose: OTHER

Brief summary: Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve.

The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during DSA in lower extremity diagnostic angiographies with non-inferior image quality.

The aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography.

The project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional DSA using a standard care protocol (Siemens Artis Zee, Extremities Care setting, 1.2 µGy/frame) (Group B) and a study group examined by means of DVA using a low-dose protocol (0.36 µGy/frame corresponding to 70% decrease of radiation dose) (Group A). During each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. Qualitative image review is done to compare conventional DSA and reduced radiation exposure DVA images after image acquisition.

Our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with lower limb peripheral arterial disease, admitted for diagnostic angiography
* Fontaine II- IV
* Normal renal function: GFR\> 60ml/min/m2
* Age \> 18

Exclusion Criteria:

* Acute myocardial infarction
* Severe heart/liver/renal failure
* Iodine contrast allergy
* Atrioventricular block
* Coagulopathy and Hematological Bleeding Disorders

Primary outcomes:
measure: Total procedural Dose-area product(DAP)
timeFrame: During the procedure
measure: Total DSA-related DAP
timeFrame: During the procedure
measure: Image quality review
timeFrame: Upon completion of enrollment, approximately 1-year period
measure: TASC classification
timeFrame: Upon completion of enrollment, approximately 1-year period
Secondary outcomes:
measure: Contrast media usage
timeFrame: During the procedure
measure: Number of protocol change
timeFrame: During the procedure
measure: Procedure time
timeFrame: During the procedure
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Heart and Vascular Center
Study officials:
affiliation: Kinepict Health Ltd.
name: Krisztián Szigeti, Ph.D.
role: STUDY_CHAIR
affiliation: Kinepict Health Ltd.
name: Szabolcs Osváth, Ph.D.
role: STUDY_CHAIR
affiliation: Kinepict Health Ltd.
name: János Kiss, M.D.,Ph.D.,D.Sc.
role: STUDY_CHAIR
References:
citation: Orias VI, Gyano M, Gog I, Szollosi D, Veres DS, Nagy Z, Csobay-Novak C, Zoltan O, Kiss JP, Osvath S, Szigeti K, Zoltan R, Sotonyi P. Digital Variance Angiography as a Paradigm Shift in Carbon Dioxide Angiography. Invest Radiol. 2019 Jul;54(7):428-436. doi: 10.1097/RLI.0000000000000555.
citation: Gyano M, Gog I, Orias VI, Ruzsa Z, Nemes B, Csobay-Novak C, Olah Z, Nagy Z, Merkely B, Szigeti K, Osvath S, Sotonyi P. Kinetic Imaging in Lower Extremity Arteriography: Comparison to Digital Subtraction Angiography. Radiology. 2019 Jan;290(1):246-253. doi: 10.1148/radiol.2018172927. Epub 2018 Oct 16.