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Hemodynamic Instability Following Carotid Artery Stenting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056445
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : January 26, 2010
Information provided by:
Shiraz University of Medical Sciences

Brief Summary:
Hemodynamic instability was controlled in 27 patient during carotid stenting and it was showed that hemodynamic instability can be predicted by Valsalva maneuver before stenting and hemodynamic instability have no prognostic effect on result of carotid stenting.

Condition or disease Intervention/treatment Phase
Carotid Stenting Procedure: valsalva maneuver Not Applicable

Detailed Description:

One of the important complications of Carotid Artery Stenting (CAS) is post procedural hypotension and bradycardia referred to as Hemodynamic Instability (HI). However its incidence and contribution to short-term prognosis of patients have been of a large debate. In this study we aim to assess the incidence and predictive factors of HI and its role in mortality and morbidity of patients in short-term follow-up.

Materials and Methods: 27 patients were selected based on NASCET criteria and underwent CAS between September 2008 and September 2009. Continuous EKG monitoring & supine blood pressure (BP) was obtained before and after stent deployment and on the following day to detect HI defined as systolic BP≤90mmHg or heart rate≤60 beats per minute. Patients were asked to perform Valsalva maneuver before and after stent deployment. Valsalva ratio along with other demographic and procedural data was documented and compared between patients with and without incidence of HI.

Results: 17 patients (63%) developed HI after CAS. The degree of stenosis was found to have a significant correlation with occurrence of HI with P value<0.006. No other risk factor or demographic data showed any correlation with HI. Valsalva Ratio (VR) were significantly lower in HI group compared with non-HI group indicating a significant autonomic dysfunction (P<0.003). In the follow-up one (4.3%) patient had developed major stroke and others were symptom free.

Conclusion: HI occurs frequently following CAS but seems to be a benign phenomenon and doesn't increase the risk of mortality or morbidity after the procedure in short-term. VR at rest (VR≤1.10) baseline autonomic dysfunction and degree of carotid artery stenosis can be used as measures for prediction of HI after CAS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Hemodynamic Instability Following Carotid Artery Stenting
Study Start Date : May 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Active Comparator: carotid stenting and hemodynamic instability
27 patients undergone carotid stenting
Procedure: valsalva maneuver
valsalva maneuver after carotid stenting

Active Comparator: carotid stenting without hemodynamic instability
no hemodynamic instability after carotid stenting
Procedure: valsalva maneuver
valsalva maneuver after carotid stenting

Primary Outcome Measures :
  1. predictors of hemodynamic instability [ Time Frame: 0, 1, 6 months ]

Secondary Outcome Measures :
  1. result of carotid stenting [ Time Frame: 0, 1, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • every patient with carotid stenting

Exclusion Criteria:

  • presence of hemodynamic instability and low BP at baseline
  • atrial fibrillation
  • unstable patients with recent TIA and CVA in last week
  • inability of patient to hold respiration for 30 seconds
  • refusal of patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056445

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Iran, Islamic Republic of
Shiraz University of Medical Sciences, Cardiovascular Research Center
Shiraz, Fars, Iran, Islamic Republic of, 553418
Sponsors and Collaborators
Shiraz University of Medical Sciences
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Principal Investigator: javad kojuri, M.D. shiraz University of medical asciences
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Javad Kojuri, Shiraz Univ ersity of medical Sciences Identifier: NCT01056445    
Other Study ID Numbers: 88-1239
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: March 2008
Keywords provided by Shiraz University of Medical Sciences:
Carotid artery stenting
Hemodynamic Instability
Valsalva Ratio