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OpenTrials
Completed

NCT Number: NCT01056445

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.

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Key information

Conditions

Carotid Stenting

Age range

49 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz University of Medical Sciences, Cardiovascular Research Center

Shiraz, Fars, 553418, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsalva maneuver

Procedure

valsalva maneuver after carotid stenting

Primary outcomes

  1. predictors of hemodynamic instability

    Time frame: 0, 1, 6 months

Secondary outcomes

  1. result of carotid stenting

    Time frame: 0, 1, 6 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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