Skip to content

Hemodynamic Instability Following Carotid Artery Stenting

Hemodynamic Instability Following Carotid Artery Stenting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01056445
Enrollment
27
Registered
2010-01-26
Start date
2008-05-31
Completion date
2009-10-31
Last updated
2010-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenting

Keywords

Carotid artery stenting, Hemodynamic Instability, Valsalva Ratio

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.

Interventions

valsalva maneuver after carotid stenting

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
49 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
predictors of hemodynamic instability0, 1, 6 months

Secondary

MeasureTime frame
result of carotid stenting0, 1, 6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026