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Study Protocol

Comparative study of arterial doppler with digital subtraction angiography in lower limb peripheral arterial disease: a protocol

[version 1; peer review: 1 not approved]
PUBLISHED 22 Mar 2024
Author details Author details
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REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

One of the serious cardiovascular conditions is peripheral arterial disease; in which distinctive feature is diminished blood supply towards the lower extremities, frequently because of atherosclerotic occlusive disease.

Methods

We will compare arterial Doppler with digital subtraction angiography in peripheral lower limb occlusive arterial sickness; to determine Peripheral Arterial Disease along with its location and stenosis severity on Duplex Ultra-Sonography and Digital Subtraction Angiography; and to determine the segment-to-segment agreement of the arterial tree within Duplex Ultra-Sonography and Digital Subtraction Angiography.

Implications

This will encourage the participants for periodic investigation and proper use of medications which will improve hospital/facility outcome. It will be helpful for older individuals how are more susceptible to peripheral artery disease. A fair accurate treatment options will be given to patients.

Limitations

Findings will only be applicable to our organization because the study will be done at one tertiary care hospital, limiting their external validity and generalizability.

Keywords

peripheral arterial disease, smoking, on Duplex Ultra-Sonography, Digital Subtraction Angiography.

Introduction

Peripheral arterial disease (PAD) is a major cardiovascular condition, presenting with deficient blood supply affecting the lower extremities, frequently as a result of atherosclerotic occlusive disease.1

Approximately 10% to 25% of people over the age of 55 have PAD in their lower limbs, and the frequency rises with age. The most prominent risk factors for peripheral arterial disease include being over the age of 50 years, experiencing diabetic complications, engaging in nicotine consumption, and having dyslipidemia.2 PAD itself poses a risk factor for coronary disease regardless of severity as well as for brain-vascular incidents. Individuals with PAD have a possibility of death within 10 years as compared to those without the disease.2

Patients with PAD might show symptoms or might not. The size and location of the affected artery, the extent of collateral circulation as well as the metabolic demands placed on the ischemic tissue during exercise, all of this influence the presence of symptoms.3 The majority of symptomatic individuals present with claudication, rest pain, colour changes of the limb, local tissue loss, and gangrene. An amputation may be necessary in severe cases.3

Digital subtraction angiography represents a minimally invasive technique that serves as the standard approach for percutaneous revascularization therapy in non-responsive patients with medical therapy. But while working with people who have destructive lower limb ischemia, for appropriate therapy, re-planning, and evaluation of subsequent treatment outcomes and consequences, proper interpretation of diagnostic DSA findings is essential.4 Several other alternative imaging procedures including Duplex Ultrasound, CT and MR angiographies, and Intra-arterial Contrast Angiography are also available.

DUS is usually the first investigation of choice, owing to its easy availability, low cost, and the non-invasive nature of the procedure. However, it does not come without its limitations. DUS is largely operator dependent; hence the user’s level of expertise can affect its quality. Moreover, deep-seated arteries, such as the infragenicular arteries in the lower limbs may prove difficult to assess, particularly if edema is present.2 In addition to giving insight into the vessel’s morphology and activity, color Doppler imaging also provides detail about the vessel’s wall.5

Even though digital subtraction arteriography has been around for a while, duplex ultrasonography is still a common imaging method utilized in most vascular centers.6 On the other hand digital subtraction arteriography can be used for therapeutic as well as diagnostic purposes. With this technique, deep-seated arteries can be better visualized and smaller vessels and collaterals with the slow flow can be detected. Nonetheless, its shortcomings lie in its high radiological risk, kidney failure, and the invasive nature of the treatment all must be considered. DSA is frequently associated with post-procedure complications such as hematoma, aneurysms, and thromboembolism.2

There are other causes of PAD; The main factor causing PAD is atherosclerosis. Stroke and myocardial infarction risk are decreased by medical treatment that targets atherosclerotic risk factors which are the main factors that lead to mortality in people with PAD.7

Maximum systolic velocity at the location of a blockage can be used to measure variations in a cross-sectional area of the arterial lumen.8

Rationale

Management strategies differ for patients with lower extremities arterial illnesses. While Angioplasty is frequently used to treat individuals with ischemia that poses a risk to their limbs, Amputation or revascularization via surgery, Conservative management is usually used for temporary claudication.

The appropriate line of action is determined by the disease’s intensity, this may call for pairing therapies. Hence, individuals with limb-threatening ischemia need to be thoroughly evaluated. A proper treatment plan for each patient can be created with the help of knowledge about agreement between two different treatment modes, invasive and non-invasive.

Aim: To compare arterial Doppler with digital subtraction angiography in distal occlusive arterial disorders of the lower limbs.

Objectives

  • 1. To evaluate risk factors for Peripheral Occlusive Arterial Disorder.

  • 2. To assess the presence, location, and severity of stenosis in Peripheral Arterial Disease using Duplex Ultrasonography.

  • 3. To assess the presence, location, and severity of stenosis in Peripheral Arterial Disease using Digital Subtraction Angiography.

  • 4. To determine the segment-to-segment agreement of the arterial tree between Digital Subtraction Angiography and Duplex Ultrasonography.

Methods

Study design: The research shall be Prospective cross-sectional which will be executed in hospital.

Study setting: Sawangi, Wardha, Maharashtra’s Acharya Vinoba Bhave Rural Hospital’s radiology department will carry out this research. Hospital offering tertiary care that is fully equipped.

Study population: Patients with complaint of peripheral vascular disease who would be due for duplex ultra-Sonography or digital subtraction angiography and patients with clinical suspicion of PAD reporting to OPD. Meeting the criteria for inclusion and exclusion in the study.

Study period: 2 years

Type of sampling: purposive sampling will be used in this study.

Formula:

Alpha=0.05
Beta=0.2
Proportion in group1=0.88Duplex Ultra-Sonography
Proportion in group2=0.99Digital Subtraction Angiography

Sample size: The investigations will take place among patients seeking treatment for peripheral vascular disease; a total number of 78 patients will be enrolled. The list of patients undergoing treatment or opd patients will be obtained from respective sister incharge.

Inclusion criteria

  • 1. Individuals who have a clinical suspicion of having peripheral artery disease.

  • 2. Patients of age over the age of 18.

  • 3. Patients ready to take part in the investigation.

  • 4. Giving the history of chronic peripheral vascular disease.

Exclusion criteria

  • 1. Pregnant woman

  • 2. Patients with blood disorders

  • 3. Those who are vulnerable to contrast agents

  • 4. Patients with prior angioplasty or vascular procedures

  • 5. Patient less than 18 years of age.

Data collection tools and procedure

The examination will be stated and reports including causes, signs and symptoms, and consequences will be acquired from patients via interview (themes shown in Table 1). It will be noted whether there are any peripheral pulses or bruits.

Table 1. Interview themes.

Serial numberQuestion
1History of present illness: Intermittent pain/rest pain/ulceration/gangrene
2Comorbidities: Diabetes/Hypertension/Ischemic heart disease
3History of smoking
4Previous surgery if any

Duplex ultrasonography - Aloka Hitachi USG machine Arietta S70 with linear frequency probe 12-18 mega Hz with colour Doppler.

The procedure will be explained to the patient before and after taking consent with colour-coded duplex Sonography, Doppler measurements, and wave-form analysis, throughout the aortic branching to the area of the leg, the entire arterial tree of the target limb will be examined.

Digital substraction angiography - performed using a Philips Azurion 7 M12 angiography unit.

The procedure will be explained to the patient and consent will be taken. Patients planned for DSA will be investigated for all routine scan including HIV & HBsAg.

Under strict sterile management and observation of an anaesthesiologist femoral artery punctured in a patient lying on your back after getting at the associated vessel via the Transfemoral path, dye will be infused with the catheter into the targeted vessel.

Study variables

  • 1. Social and demographic details

  • 2. Hypertension, smoking, alcohol, diabetes mellites, hyperlipidaemia.

Statistical analysis

Protocol among Duplex-Ultrasonography and Digital Subtraction Angiography will be assessed using kappa (k) statistics and Sensitivity, Specificity, Positive Predictive Value; Negative Predictive Value will be assessed using appropriate statistical tests. SPSS software will be used.

Information will be displayed as graphical representations, statistics, and illustrations. The results will be examined and compared with those of other studies that will be comparable.

Implications

  • This will encourage the participants for periodic investigation and proper use of medications which will improve hospital/facility outcome.

  • It will be helpful for the condition of peripheral arteries is more common in older adults.

  • Further accurate treatment options will be given to patients.

Study status

Post IEC approval, data of 24 patients has been collected so far.

Dissemination

Results will be made available to the institutional scientific committee. The research will be presented at national and international diagnostic/intervention radiology conferences, it will also be submitted as an original article to peer-reviewed journals.

Ethical consideration

Institutional ethics committee permission from the ethics committee has been received on 21.03.2023 from the DMIHER University.

Ref.No. DMIMS (DU)/IEC/2023/765

Informed consent

All the participants selected for the study will be explained in detail regarding the research proposal; signed consent and information will be kept enclosed.

Disscusion

Outcome measure

Outcome would be measured in terms of agreement between degree of stenosis detected for different segments with Duplex-Ultrasonography and Digital Subtraction Angiography and to evaluate threat components for Peripheral Occlusive Arterial Disease along with its location and stenosis.

Conclusion

  • The condition of peripheral arteries is more likely to affect elderly individuals.

  • Tobacco use is one of the most prevalent contributory factors that affect men.

Limitations

Findings will only be applicable to our organization because the study will be done at one tertiary care hospital, limiting their external validity and generalizability.

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Version 1
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how to cite this article
Shrivastava P and Kashikar S. Comparative study of arterial doppler with digital subtraction angiography in lower limb peripheral arterial disease: a protocol [version 1; peer review: 1 not approved]. F1000Research 2024, 13:214 (https://doi.org/10.12688/f1000research.142079.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 22 Mar 2024
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Reviewer Report 29 May 2024
Sanjum Sethi, Columbia University Irving Medical Center, New York, New York, USA 
Sonal Pruthi, Columbia University (Ringgold ID: 5798), New York, New York, USA 
Not Approved
VIEWS 9
The current study aims to compare use of Doppler ultrasound to traditional digital subtraction angiography in patients with lower extremity peripheral arterial disease.
The paper is extremely unclear as to the main objective of the analysis and what question ... Continue reading
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CITE
HOW TO CITE THIS REPORT
Sethi S and Pruthi S. Reviewer Report For: Comparative study of arterial doppler with digital subtraction angiography in lower limb peripheral arterial disease: a protocol [version 1; peer review: 1 not approved]. F1000Research 2024, 13:214 (https://doi.org/10.5256/f1000research.155577.r262528)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 22 Mar 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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