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
About this trial
This is an interventional diagnostic trial for Pulsatile Tinnitus (Diagnosis)
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
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
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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Role of the Radiologist in Management of Pulsatile Tinnitus
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