Carotid StentingNCT01056445
Hemodynamic Instability Following Carotid Artery Stenting
A study testing valsalva maneuver in people with Carotid Stenting, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 80 years
- Conditions the study is for
- Carotid Stenting
- What is being tested?
- valsalva maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIran
- Study dates
- May 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- every patient with carotid stenting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shiraz University of Medical Sciences, Cardiovascular Research Center
Shiraz, Fars, 553418
About this study
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.
Read the 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
- Carotid Stenting
- Being tested
- valsalva maneuver
- Keywords
- Carotid artery stenting, Hemodynamic Instability, Valsalva Ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsalva maneuverProcedure or surgery
valsalva maneuver after carotid stenting
valsalva maneuverProcedure or surgery
valsalva maneuver after carotid stenting
| Study group | Role | What they receive |
|---|---|---|
| carotid stenting and hemodynamic instability | Active comparator | 27 patients undergone carotid stenting Receives: Procedure: valsalva maneuver |
| carotid stenting without hemodynamic instability | Active comparator | no hemodynamic instability after carotid stenting Receives: Procedure: valsalva maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of hemodynamic instability
Measured: 0, 1, 6 months
Secondary outcomes (1)
result of carotid stenting
Measured: 0, 1, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMay 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- javad kojuri, M.D., Principal investigator, shiraz University of medical asciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056445
- Sponsor's protocol ID
- 88-1239
- Status last verified
- Mar 2008
- First submitted
- 19 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21631213
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Instability Following Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT01056445
- Acronym / sponsor ID
- 88-1239
- Conditions
- Carotid Stenting
- Keywords
- Carotid artery stenting, Hemodynamic Instability, Valsalva Ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carotid stenting and hemodynamic instability | Active comparator | Procedure: valsalva maneuver27 patients undergone carotid stenting |
| carotid stenting without hemodynamic instability | Active comparator | Procedure: valsalva maneuverno hemodynamic instability after carotid stenting |
Who may qualify
- Ages
- 49 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- every patient with carotid stenting
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsalva maneuvervalsalva maneuver after carotid stenting | Procedure or surgery | carotid stenting and hemodynamic instability |
| valsalva maneuvervalsalva maneuver after carotid stenting | Procedure or surgery | carotid stenting without hemodynamic instability |
Primary outcome
predictors of hemodynamic instability
Time frame: 0, 1, 6 months
1 secondary outcome
result of carotid stenting
Time frame: 0, 1, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
- Derived from this study: PubMed 21631213Kojuri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
javad kojuri, M.D. principal investigator
shiraz University of medical asciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valsalva maneuver in people with Carotid Stenting, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of hemodynamic instability (time frame: 0, 1, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.