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Role of the Radiologist in Management of Pulsatile Tinnitus

Primary Purpose

Pulsatile Tinnitus (Diagnosis)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colour doppler,MSCT,MRI
Sponsored by
Mohab Mohammed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulsatile Tinnitus (Diagnosis)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with pulsatile tinnitus of unknown origin referred by a physician to diagnostic radiology to be assessed by imaging will be included in the study.
  • Patient's with clinical diagnosed pulsatile tinnitus.
  • patient refused surgical intervention.

Exclusion Criteria:

  • History of allergy to the contrast media , Contraindication to MRI and Refusal to sign a consent
  • Pregnant women
  • patients with atherosclerosis cause only or vascular loop more than 50% in internal auditory canal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    diagnostic catheter intervention then therapeutic if indicated

    Arm Description

    Outcomes

    Primary Outcome Measures

    Manage pulsatile tinnitus with catheter angiography to all vascular lesion
    Manage pulsatile tinnitus causes with no indication for surgical intervention or prolonged and follow up and detect reported cases with pulsatile tinnitus could be managed by therapeutic angiography rather than other invasive surgical maneuver or Medical treatment

    Secondary Outcome Measures

    To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus .
    Detect accurate cause of pulsatile tinnitus and the best imaging for diagnosis with measurement of the percentage of indicated patient for therapeutic angiography rather than surgical intervention or follow up with medical treatment .

    Full Information

    First Posted
    April 2, 2022
    Last Updated
    April 16, 2022
    Sponsor
    Mohab Mohammed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05338684
    Brief Title
    Role of the Radiologist in Management of Pulsatile Tinnitus
    Official Title
    Role of the Radiologist in Management of Pulsatile Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 17, 2022 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohab Mohammed

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to detect the role of interventional radiology in management of Pulsatile tinnitus and to detect the best imaging modality for Diagnosis.
    Detailed Description
    Tinnitus is a broad and complex subject concerning a symptom rather than a syndrome or a disease (1 ),New studies indicate that prevalence of tinnitus is 14.5% among those less than 40 years old and 17.5 - 35% among age over 40 years Old( 2-3 ). Vascular tinnitus causes are multiple , Arterial causes like Atherosclerosis , Fibromuscular dysplasia or Dissection of the carotid or vertebral artery , Arteriovenous causes like Cerebral head and neck arteriovenous malformation , Dural arteriovenous fistula and Carotid cavernous fistula Venous like Systemic diseases with hyperdynamic circulation . Chronic anemia, pregnancy, thyrotoxicosis , Idiopathic intracranial hypertension and Dural venous sinus stenosis , Tumors also like Paraganglioma which Some authors believe that para-gangliomas are the most common cause of vascular tinnitus and Vascular metastasis And other Miscellaneous Causes like Paget's disease m Otosclerosis or Otomastoiditis , but others see dural arteriovenous fistula (AVF) ,idiopathicvenous tinnitus, or idiopathic intracranial hypertension the most common causes. (4 - 9) , Also One of the Most important Arterial causes is Atherosclerosis , Atherosclerotic plaques ma produce turbulence of carotid flow and occasionally cause pulsatile tinnitus (10 ) , FMD ( Fibromuscular Dysplasia ) seen in 0.5% to0.6% of carotid angiograms and autopsies, is the second most common cause of extracranial carotid narrowing (11) information obtained from both CT and MRI is complementary In some casesThe angiographic findings may include luminal stenosis, abrupt reconstitution of the lumen, dissecting aneurysm, intimal flap, slow flow, occlusion, and distal emboli (12-15)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulsatile Tinnitus (Diagnosis)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients diagnosed with pulsatile tinnitus clinically
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    diagnostic catheter intervention then therapeutic if indicated
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Colour doppler,MSCT,MRI
    Intervention Description
    ultrasound/color duplex at Jugular veins & carotid and vertebral arteries first ,then MSCT/CTA mainly with relation of neck & Bain arteries to the bone of the skull in 6 mm cuts and/or MRI/MRA/MRV by standardized multi-parametric MR protocol will be implemented for all patients. All sequences will be acquired on a 1.5T MR scanner.
    Primary Outcome Measure Information:
    Title
    Manage pulsatile tinnitus with catheter angiography to all vascular lesion
    Description
    Manage pulsatile tinnitus causes with no indication for surgical intervention or prolonged and follow up and detect reported cases with pulsatile tinnitus could be managed by therapeutic angiography rather than other invasive surgical maneuver or Medical treatment
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    To assess the accuracy of best imaging modality to diagnose pulsatile tinnitus .
    Description
    Detect accurate cause of pulsatile tinnitus and the best imaging for diagnosis with measurement of the percentage of indicated patient for therapeutic angiography rather than surgical intervention or follow up with medical treatment .
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with pulsatile tinnitus of unknown origin referred by a physician to diagnostic radiology to be assessed by imaging will be included in the study. Patient's with clinical diagnosed pulsatile tinnitus. patient refused surgical intervention. Exclusion Criteria: History of allergy to the contrast media , Contraindication to MRI and Refusal to sign a consent Pregnant women patients with atherosclerosis cause only or vascular loop more than 50% in internal auditory canal
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohab Mohammed, Dem
    Phone
    01555151888
    Email
    mohabmohammed812@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hany Mohamed, Prof
    Phone
    01005618665
    Email
    hanyseifrad@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12596495
    Citation
    Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.
    Results Reference
    background
    PubMed Identifier
    12856294
    Citation
    Heller AJ. Classification and epidemiology of tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):239-48. doi: 10.1016/s0030-6665(02)00160-3.
    Results Reference
    background
    PubMed Identifier
    21162777
    Citation
    Mehanna R, Shaltoni H, Morsi H, Mawad M. Endovascular treatment of sigmoid sinus aneurysm presenting as devastating pulsatile tinnitus. A case report and review of literature. Interv Neuroradiol. 2010 Dec;16(4):451-4. doi: 10.1177/159101991001600413. Epub 2010 Dec 17.
    Results Reference
    background
    PubMed Identifier
    6946175
    Citation
    Schleuning A. Neurotologic evaluation of subjective idiopathic tinnitus. J Laryngol Otol Suppl. 1981;(4):99-101. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8059655
    Citation
    Dietz RR, Davis WL, Harnsberger HR, Jacobs JM, Blatter DD. MR imaging and MR angiography in the evaluation of pulsatile tinnitus. AJNR Am J Neuroradiol. 1994 May;15(5):879-89.
    Results Reference
    background
    PubMed Identifier
    6864262
    Citation
    George B, Reizine D, Laurian C, Riche MC, Merland JJ. Tinnitus of venous origin. Surgical treatment by the ligation of the jugular vein and lateral sinus jugular vein anastomosis. J Neuroradiol. 1983;10(1):23-30. No abstract available. English, French.
    Results Reference
    background
    PubMed Identifier
    9661757
    Citation
    Sismanis A. Pulsatile tinnitus. A 15-year experience. Am J Otol. 1998 Jul;19(4):472-7.
    Results Reference
    background
    PubMed Identifier
    12856306
    Citation
    Sismanis A. Pulsatile tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):389-402, viii. doi: 10.1016/s0030-6665(02)00169-x.
    Results Reference
    background
    PubMed Identifier
    9553842
    Citation
    Waldvogel D, Mattle HP, Sturzenegger M, Schroth G. Pulsatile tinnitus--a review of 84 patients. J Neurol. 1998 Mar;245(3):137-42. doi: 10.1007/s004150050193.
    Results Reference
    background
    PubMed Identifier
    7070118
    Citation
    Sandok BA, Whisnant JP, Furlan AJ, Mickell JL. Carotid artery bruits: prevalence survey and differential diagnosis. Mayo Clin Proc. 1982 Apr;57(4):227-30.
    Results Reference
    background
    PubMed Identifier
    7295104
    Citation
    Corrin LS, Sandok BA, Houser OW. Cerebral ischemic events in patients with carotid artery fibromuscular dysplasia. Arch Neurol. 1981 Oct;38(10):616-8. doi: 10.1001/archneur.1981.00510100044005.
    Results Reference
    background
    PubMed Identifier
    2046892
    Citation
    Gelbert F, Assouline E, Hodes JE, Reizine D, Woimant F, George B, Hagueneau M, Merland JJ. MRI in spontaneous dissection of vertebral and carotid arteries. 15 cases studied at 0.5 tesla. Neuroradiology. 1991;33(2):111-3. doi: 10.1007/BF00588245.
    Results Reference
    background

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