Hemodynamic Instability Following Carotid Artery Stenting

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01056445
First received: January 19, 2010
Last updated: January 25, 2010
Last verified: March 2008

January 19, 2010
January 25, 2010
May 2008
October 2009   (final data collection date for primary outcome measure)
predictors of hemodynamic instability [ Time Frame: 0, 1, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056445 on ClinicalTrials.gov Archive Site
result of carotid stenting [ Time Frame: 0, 1, 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hemodynamic Instability Following Carotid Artery Stenting
Hemodynamic Instability Following Carotid Artery Stenting

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.

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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Carotid Stenting
Procedure: valsalva maneuver
valsalva maneuver after carotid stenting
  • Active Comparator: carotid stenting and hemodynamic instability
    27 patients undergone carotid stenting
    Intervention: Procedure: valsalva maneuver
  • Active Comparator: carotid stenting without hemodynamic instability
    no hemodynamic instability after carotid stenting
    Intervention: Procedure: valsalva maneuver
Kojuri J, Ostovan MA, Zamiri N, Farshchizarabi S, Varavipoor B. Hemodynamic instability following carotid artery stenting. Neurosurg Focus. 2011 Jun;30(6):E12. doi: 10.3171/2010.12.FOCUS10219.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
49 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01056445
88-1239
Yes
Javad Kojuri, Shiraz Univ ersity of medical Sciences
Shiraz University of Medical Sciences
Not Provided
Principal Investigator: javad kojuri, M.D. shiraz University of medical asciences
Shiraz University of Medical Sciences
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP