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Hemodynamic Instability Following Carotid Artery Stenting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056445
First Posted: January 26, 2010
Last Update Posted: January 26, 2010
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.
Information provided by:
Shiraz University of Medical Sciences
  Purpose
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 Intervention
Carotid Stenting Procedure: valsalva maneuver

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Hemodynamic Instability Following Carotid Artery Stenting

Further study details as provided by Shiraz University of Medical Sciences:

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

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

Enrollment: 27
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01056445


Locations
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
Investigators
Principal Investigator: javad kojuri, M.D. shiraz University of medical asciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javad Kojuri, Shiraz Univ ersity of medical Sciences
ClinicalTrials.gov Identifier: NCT01056445     History of Changes
Other Study ID Numbers: 88-1239
First Submitted: January 19, 2010
First Posted: January 26, 2010
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