Aortic StenosisNCT00329979
Femoral vs Radial Approach and MRI Evaluation of Strokes
An observational study of Aortic Stenosis, run by University Hospital, Caen at 1 site in France.
Trial summary
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- vascular access site
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Sep 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with aortic stenosis
Who may be able to join
- Patient with significant aortic valve stenosis before planned surgery.
Who cannot join
- Contraindication to MRI or inability to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI.
Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.
- Conditions
- Aortic Stenosis
- Being tested
- vascular access site
- Keywords
- aortic stenosis, radial, femoral, vascular access site, embolism, cerebral, MRI, stroke
- Medical subject headings
- Aortic Valve Stenosis, Embolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular access siteBehavioural
Randomized vascular access site
| Study group | Role | What they receive |
|---|---|---|
| 1 | Radial access Receives: Behavioral: vascular access site | |
| 2 | Femoral access Receives: Behavioral: vascular access site |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Michèle Hamon, MD, Study chair, University Hospital, CaenMartial Hamon, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329979
- Sponsor's protocol ID
- 2006-18
- Other IDs
- No additional Ids
- Status last verified
- Jun 2010
- First submitted
- 23 May 2006
- Last updated
- 10 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.
- ClinicalTrials.gov ID
- NCT00329979
- Acronym / sponsor ID
- 2006-18
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, radial, femoral, vascular access site, embolism, cerebral, MRI, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 May 2006 (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.
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI.
Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: vascular access siteRadial access |
| 2 | – | Behavioral: vascular access siteFemoral access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with aortic stenosis
Key inclusion criteria (1 listed)
- Patient with significant aortic valve stenosis before planned surgery.
Key exclusion criteria (1 listed)
- Contraindication to MRI or inability to give written informed consent.
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 |
|---|---|---|
| vascular access siteRandomized vascular access site | Behavioural | 1, 2 |
Primary outcome
Not reported in the source record.
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 10 Jun 2010.
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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.
Michèle Hamon, MD study chair
University Hospital, Caen
Martial Hamon, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by University Hospital, Caen at 1 site in France.
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 1 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 10 Jun 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 France. 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.
Where can I read the original study information?
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 10 Jun 2010.