Clinical Trials Directory

Trials / Completed

CompletedNCT01056445

Hemodynamic Instability Following Carotid Artery Stenting

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Shiraz University of Medical Sciences · Academic / Other
Sex
All
Age
49 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREvalsalva maneuvervalsalva maneuver after carotid stenting
PROCEDUREvalsalva maneuvervalsalva maneuver after carotid stenting

Timeline

Start date
2008-05-01
Primary completion
2009-10-01
Completion
2009-10-01
First posted
2010-01-26
Last updated
2010-01-26

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT01056445. Inclusion in this directory is not an endorsement.