Clinical trial NCT01056445: Hemodynamic Instability Following Carotid Artery Stenting
Official title: Hemodynamic Instability Following Carotid Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenting
Keywords: Carotid artery stenting
Hemodynamic Instability
Valsalva Ratio
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 27
Sex: ALL
Minimum age (years): 49
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: predictors of hemodynamic instability
timeFrame: 0, 1, 6 months
Secondary outcomes:
measure: result of carotid stenting
timeFrame: 0, 1, 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences, Cardiovascular Research Center
state: Fars
Study officials:
affiliation: shiraz University of medical asciences
name: javad kojuri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.