Ischemic StrokeAVC/SCANCT00926874
Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
An observational study of Ischemic Stroke and Acute Coronary Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ischemic Stroke, Acute Coronary Syndrome, Obstructive Sleep Apnea Syndrome
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to Oct 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who presented an acute vascular event :an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).
Who may be able to join
- Male and female patients
- Between 40 and 70 years of age
- Who have given their written consent
- Who have presented the following between 5 and 30 days prior to inclusion:
- either an ischaemic stroke (full stroke or TIA) that has been stabilised from a neurological point of view, with no haemorrhage but with direct signs of ischaemia on the cerebral imaging (computed tomography or MRI), diagnosed during patient questioning and/or the clinical examination;
- or an ACS that has been stabilised from a cardiological point of view, with troponin elevation in at least 2 samples and/or ECG changes that indicate acute myocardial ischaemia, diagnosed during patient questioning.
- Who are affiliated to the French social security system
Who cannot join
- For patients included in the ACS group
- Stroke less than 6 months ago
- Coronary bypass between the start of their hospitalisation for ACS and inclusion
- For patients included in the stroke group
- Emboligenic heart disease
- ACS less than 6 months ago
Show all 10Show fewer
- For all patients
- Atrial fibrillation or flutter, or frequent extrasystole (more than 10/minute) upon inclusion
- History of surgery or carotid stenting
- Very reduced mobility meaning that they cannot remain standing without assistance or without using a walking stick
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Grenoble
Baguet Jean-Philippe, Professor, 0033476768480, JPBaguet@chu-grenoble.fr
About this study
Official title: A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.
The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.
Read the detailed description
A comparative study of structural and functional arterial properties after an ischaemic stroke or an acute coronary syndrome
Objectives:
Primary:
- To determine whether there is a difference in the biomechanical properties of the carotid arteries, assessed by studying their stiffness, after an acute vascular event, depending on whether the event is an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).
Secondary:
- To determine whether there is a difference in aortic stiffness and brachial endothelial function after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
- To compare the blood pressure (BP) levels and the vascular parameters of the two patient groups (the ischaemic stroke group and the ACS group).
- To determine whether there is a difference between the respiratory parameters recorded during sleep after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
- Keywords
- ischaemic stroke, acute coronary syndrome, obstructive sleep apnea syndrome, brachial endothelial function, blood pressure, aortic stiffness
- Medical subject headings
- Ischemic Stroke, Acute Coronary Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients who presented an ischaemic stroke(full stroke or TIA) | |
| 2 | patients who present an acute coronary syndrome (ACS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomechanical properties of the carotid arteries
Measured: 1-6 months
Secondary outcomes (3)
aortic stiffness and brachial endothelial function
Measured: 1-6 months
blood pressure (BP) levels and the vascular parameters
Measured: 1-6 months
respiratory parameters recorded during sleep
Measured: 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 posted24 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
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 Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- BAGUET Jean Philippe, Professor, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926874
- Sponsor's protocol ID
- 0401
- Other IDs
- DGS 2008/0443
- Acronym
- AVC/SCA
- Status last verified
- Aug 2009
- First submitted
- 23 Mar 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Barone-Rochette G, Vanzetto G, Detante O, Quesada JL, Hommel M, Mallion JM, Baguet JP. Imaging of functional and structural alterations of large arteries after acute ischaemic atherothrombotic stroke or acute coronary syndromes. Arch Cardiovasc Dis. 2014 Aug-Sep;107(8-9):443-51. doi: 10.1016/j.acvd.2014.05.007. Epub 2014 Jul 10.
PubMed 25023004
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00926874
- Acronym / sponsor ID
- AVC/SCA / 0401
- Keywords
- ischaemic stroke, acute coronary syndrome, obstructive sleep apnea syndrome, brachial endothelial function, blood pressure, aortic stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 24 Jun 2009 (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.
A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.
The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.
Detailed description
A comparative study of structural and functional arterial properties after an ischaemic stroke or an acute coronary syndrome
Objectives:
Primary:
- To determine whether there is a difference in the biomechanical properties of the carotid arteries, assessed by studying their stiffness, after an acute vascular event, depending on whether the event is an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).
Secondary:
- To determine whether there is a difference in aortic stiffness and brachial endothelial function after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
- To compare the blood pressure (BP) levels and the vascular parameters of the two patient groups (the ischaemic stroke group and the ACS group).
- To determine whether there is a difference between the respiratory parameters recorded during sleep after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients who presented an ischaemic stroke(full stroke or TIA) |
| 2 | – | –patients who present an acute coronary syndrome (ACS). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who presented an acute vascular event :an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).
Key inclusion criteria (7 listed)
- Male and female patients
- Between 40 and 70 years of age
- Who have given their written consent
- Who have presented the following between 5 and 30 days prior to inclusion:
- either an ischaemic stroke (full stroke or TIA) that has been stabilised from a neurological point of view, with no haemorrhage but with direct signs of ischaemia on the cerebral imaging (computed tomography or MRI), diagnosed during patient questioning and/or the clinical examination;
Key exclusion criteria (10 listed)
- For patients included in the ACS group
- For patients included in the stroke group
- For all patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biomechanical properties of the carotid arteries
Time frame: 1-6 months
3 secondary outcomes
aortic stiffness and brachial endothelial function
Time frame: 1-6 months
blood pressure (BP) levels and the vascular parameters
Time frame: 1-6 months
respiratory parameters recorded during sleep
Time frame: 1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Derived from this study: PubMed 25023004Barone-Rochette G, Vanzetto G, Detante O, Quesada JL, Hommel M, Mallion JM, Baguet JP. Imaging of functional and structural alterations of large arteries after acute ischaemic atherothrombotic stroke or acute coronary syndromes. Arch Cardiovasc Dis. 2014 Aug-Sep;107(8-9):443-51. doi: 10.1016/j.acvd.2014.05.007. Epub 2014 Jul 10.
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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.
BAGUET Jean Philippe, Professor principal investigator
University Hospital, Grenoble
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 Ischemic Stroke and Acute Coronary Syndrome, run by University Hospital, Grenoble 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomechanical properties of the carotid arteries (time frame: 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 NCT00926874, 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 25 Aug 2009.