NCT01056445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
Last Updated

January 26, 2010

Status Verified

March 1, 2008

Enrollment Period

1.4 years

First QC Date

January 19, 2010

Last Update Submit

January 25, 2010

Conditions

Carotid Stenting

Keywords

Carotid artery stentingHemodynamic InstabilityValsalva Ratio

Outcome Measures

Primary Outcomes (1)

  • predictors of hemodynamic instability

    0, 1, 6 months

Secondary Outcomes (1)

  • result of carotid stenting

    0, 1, 6 months

Study Arms (2)

carotid stenting and hemodynamic instability

ACTIVE COMPARATOR

27 patients undergone carotid stenting

Procedure: valsalva maneuver

carotid stenting without hemodynamic instability

ACTIVE COMPARATOR

no hemodynamic instability after carotid stenting

Procedure: valsalva maneuver

Interventions

valsalva maneuverPROCEDURE

valsalva maneuver after carotid stenting

carotid stenting and hemodynamic instability

Eligibility Criteria

Age49 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • every patient with carotid stenting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences, Cardiovascular Research Center

Shiraz, Fars, 553418, Iran

Location

Related Publications (1)

  • 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.

    PMID: 21631213DERIVED

MeSH Terms

Interventions

Valsalva Maneuver

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • javad kojuri, M.D.

    shiraz University of medical asciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 26, 2010

Study Start

May 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 26, 2010

Record last verified: 2008-03

Locations

IR(1)