StrokeVASCUNCT02662751
Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA
A study testing Routine Imaging Assessment and LDWBA first (CT scan) in people with Stroke and Ischemic Attack, Transient, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke, Ischemic Attack, Transient
- What is being tested?
- Routine Imaging Assessment and LDWBA first (CT scan)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Oct 2019to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- The patient has given free and informed consent and signed the consent
- Patient affiliated with or beneficiary of a health insurance plan
- Patient available for 36 months of follow-up
- The patient has had a stroke (within the past 10 days, diagnosis confirmed by MRI with a diffusion sequence) or transient ischemic attack (within the past 10 days, ABCD2 score greater than 3) without haemorrhage
Who cannot join
- The patient is currently participating in or has participated in another biomedical research study within the past three months or is currently in an exclusion period determined by a previous study.
- Patient under guardianship or judicial protection
- Refusal to sign the consent
- Inability to correctly inform the patient or his/her trusted person about the study
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contraindication for a treatment used in this study
Show all 13Show fewer
- Known allergy to contrast medium or severe allergy to iodine
- Known active malignancy or history of cancer treatment
- The patient has already undergone a full body scanner in the previous three months
- Renal failure with creatinine clearance below 60 ml / min
- Monoclonal immunoglobulin
- History of severe symptomatic cardiovascular event (myocardial infarction, aortic dissection, mesenteric ischemia, renal ischemia)
- Emergency situations that hamper the planned course of the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
Alain Bonafe, MD, PhD
Vincent Costalat, MD
- Not yet recruiting
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Francesco Macri, MD
Jean Paul Beregi, MD, PhD
About this study
Official title: The Impact of Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke or Transient Ischemic Attack in Comparison With Usual Care: a Randomized, Controlled, Open Trial
The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. The first strategy is the current/usual strategy in each participating centre and the second strategy consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and subsequently resorting to elements of the usual strategy if required.
Read the detailed description
The secondary objectives are:
- To compare the patient pathways between the two arms in terms of time to diagnosis, and duration of hospitalization.
- To compare the consumption of imaging exams (number and type) and total body irradiation between the two arms.
- To compare the diagnostic efficiency between the two arms in terms of detection of predefined lesions, and performance ratios.
- To study the thickness of the left atrial wall as a risk factor for permanent atrial fibrillation.
- To compare the distribution of suspected neoplasms between the two groups, as well as the number of detected incidentalomas.
- To compare the survival and the incidence of new cardiovascular events between the two arms at 12 months and 36 months.
- To compare the quality of life between the two arms at 12 months and 36 months.
- Conditions
- Stroke, Ischemic Attack, Transient
- Being tested
- Routine Imaging Assessment, LDWBA first (CT scan)
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Imaging AssessmentOther
Patients will have the usual post-stroke/TIA imaging assessment according to routine procedures in each participating center. The latter most often begin with an angiography of the supra-aortic trunks but may also include a range of other imaging exams depending on the patient's condition.
"Routine Imaging Assessment" refers to an imaging strategy and not a specific device. The devices used depend on what is available in participating centres and the routine choices made by those centers.
LDWBA first (CT scan)Device
Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required.
LDWBA: This is a low dose scanner protocol comprising a CT acquisition and an iodine contrast medium injection. The acquisition includes a propeller during the arterial phase of the contrast agent injection in the cervical and thoracic levels with cardiac gaiting (ECG gating to reduce cardiac motion artifacts), continuing with pelvic abdominal arterial acquisition. The second propeller is made on the abdomen and pelvis at the portal time of injection. The reconstruction will be carried out in pulmonary, mediastinal and bone windows. The dose will be calculated for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Routine Imaging | Active comparator | Patients randomized to this arm will have routine post-stroke/TIA imaging assessments.
Intervention: Routine Imaging Assessment Receives: Other: Routine Imaging Assessment |
| LDWBA first | Experimental | Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required.
Intervention: LDWBA first followed by Routine Imaging Assessment if required. Receives: Other: Routine Imaging Assessment; Device: LDWBA first (CT scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of at least one element requiring specific treatment
This is a binary variable: the units are "presence/absence".
Presence/absence of at least one element (found during the patient's pathway in the imaging service) requiring specific treatment from among the following:
- Anomaly indicating a high risk for cardio-vascular embolism
- Anomaly indicating a high risk for vascular thrombosis
- Any other lesions requiring specific treatment
Measured: Day 30
Secondary outcomes (32)
Diagnostic delay (h)
The time lapsed between inclusion in the study and the first etiological determination of a diagnosis.
Thus units (h) is consistent with the time frame.
Measured: between day 1 and hospital discharge (expected maximum of two weeks)
Length of hospital stay (h)
The units are given in hours even for long stays.
Measured: hospital discharge (expected maximum of two weeks)
Patient pathway: the number of imaging exams required
Measured: Month 1
Patient pathway: the types of imaging exams required
Measured: Month 1
Total irradiation (mSv) during patient pathway
Measured: Month 1
For contrast injections during the patient pathway: total grams of iodine injected
Measured: Month 1
Number of atherosclerotic sites detected / number of imaging examinations performed
Measured: Month 1
The presence / absence of tight stenosis on the supra aortic arteries
Measured: Month 1
The presence / absence of an occlusion on the supra aortic arteries
Measured: Month 1
The presence / absence of a dissection on the supra aortic arteries
Measured: Month 1
The number of atherosclerotic lesions in the aortic arch
Measured: Month 1
For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)
Measured: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of crevices
Measured: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses
Measured: Month 1
Detection of patent foramen ovale (yes/no)
Measured: Month 1
Presence / absence of a thrombus or a circulatory stasis in the left atrium
Measured: Month 1
Extent of atherosclerosis: affects the coronary arteries? yes/no
Measured: Month 1
Extent of atherosclerosis: affects the aortic valve? yes/no
Measured: Month 1
Extent of atherosclerosis: affects the aortic arch? yes/no
Measured: Month 1
Extent of atherosclerosis: affects the abdominal aorta? yes/no
Measured: Month 1
Extent of atherosclerosis: affects the renal arteries? yes/no
Measured: Month 1
Extent of atherosclerosis: affects digestive arteries? yes/no
Measured: Month 1
Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no
Measured: Month 1
Extent of atherosclerosis: affects supra aortic trunks? yes/no
Measured: Month 1
For each detected incidentaloma: volume (mm^3)
Measured: Month 1
The thickness of the left atrial wall
Measured: Month 1
Presence / absence of paroxysmal atrial fibrillation
Measured: 36 months
Presence / absence of a cardiovascular event de novo.
Presence / absence of a cardiovascular event de novo. The following events will be searched for:
- New stroke or TIA
- Major Cardiovascular Events (acute symptomatic vascular disease)
Measured: 36 months
Survival (yes/no)
Measured: 12 months
Survival (yes/no)
Measured: 36 months
EQ-5D-5L questionnaire
Measured: 12 months
EQ-5D-5L questionnaire
Measured: 36 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 2016 (estimated)
- Study start21 Oct 2019
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Macri, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662751
- Sponsor's protocol ID
- AOI/2014/FM-01
- Other IDs
- 2015-A01600-49
- Acronym
- VASCU
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2015
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke or Transient Ischemic Attack in Comparison With Usual Care: a Randomized, Controlled, Open Trial
- ClinicalTrials.gov ID
- NCT02662751
- Acronym / sponsor ID
- VASCU / AOI/2014/FM-01
- Conditions
- Stroke, Ischemic Attack, Transient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 26 Jan 2016 (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.
The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. The first strategy is the current/usual strategy in each participating centre and the second strategy consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and subsequently resorting to elements of the usual strategy if required.
Detailed description
The secondary objectives are:
- To compare the patient pathways between the two arms in terms of time to diagnosis, and duration of hospitalization.
- To compare the consumption of imaging exams (number and type) and total body irradiation between the two arms.
- To compare the diagnostic efficiency between the two arms in terms of detection of predefined lesions, and performance ratios.
- To study the thickness of the left atrial wall as a risk factor for permanent atrial fibrillation.
- To compare the distribution of suspected neoplasms between the two groups, as well as the number of detected incidentalomas.
- To compare the survival and the incidence of new cardiovascular events between the two arms at 12 months and 36 months.
- To compare the quality of life between the two arms at 12 months and 36 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Imaging | Active comparator | Other: Routine Imaging AssessmentPatients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment |
| LDWBA first | Experimental | Other: Routine Imaging Assessment, Device: LDWBA first (CT scan)Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required. Intervention: LDWBA first followed by Routine Imaging Assessment if required. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- The patient has given free and informed consent and signed the consent
- Patient affiliated with or beneficiary of a health insurance plan
- Patient available for 36 months of follow-up
- The patient has had a stroke (within the past 10 days, diagnosis confirmed by MRI with a diffusion sequence) or transient ischemic attack (within the past 10 days, ABCD2 score greater than 3) without haemorrhage
Key exclusion criteria (13 listed)
- The patient is currently participating in or has participated in another biomedical research study within the past three months or is currently in an exclusion period determined by a previous study.
- Patient under guardianship or judicial protection
- Refusal to sign the consent
- Inability to correctly inform the patient or his/her trusted person about the study
- The patient is pregnant, parturient, or breastfeeding
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 |
|---|---|---|
| Routine Imaging AssessmentPatients will have the usual post-stroke/TIA imaging assessment according to routine procedures in each participating center. The latter most often begin with an angiography of the supra-aortic trunks but may also include a range of other imaging exams depending on the patient's condition. "Routine Imaging Assessment" refers to an imaging strategy and not a specific device. The devices used depend on what is available in participating centres and the routine choices made by those centers. | Other | LDWBA first, Routine Imaging |
| LDWBA first (CT scan)Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required. LDWBA: This is a low dose scanner protocol comprising a CT acquisition and an iodine contrast medium injection. The acquisition includes a propeller during the arterial phase of the contrast agent injection in the cervical and thoracic levels with cardiac gaiting (ECG gating to reduce cardiac motion artifacts), continuing with pelvic abdominal arterial acquisition. The second propeller is made on the abdomen and pelvis at the portal time of injection. The reconstruction will be carried out in pulmonary, mediastinal and bone windows. The dose will be calculated for each patient. | Device | LDWBA first |
Primary outcome
Presence/absence of at least one element requiring specific treatment
Time frame: Day 30
This is a binary variable: the units are "presence/absence". Presence/absence of at least one element (found during the patient's pathway in the imaging service) requiring specific treatment from among the following: * Anomaly indicating a high risk for cardio-vascular embolism * Anomaly indicating a high risk for vascular thrombosis * Any other lesions requiring specific treatment
32 secondary outcomes
Diagnostic delay (h)
Time frame: between day 1 and hospital discharge (expected maximum of two weeks)
Length of hospital stay (h)
Time frame: hospital discharge (expected maximum of two weeks)
Patient pathway: the number of imaging exams required
Time frame: Month 1
Patient pathway: the types of imaging exams required
Time frame: Month 1
Total irradiation (mSv) during patient pathway
Time frame: Month 1
For contrast injections during the patient pathway: total grams of iodine injected
Time frame: Month 1
Number of atherosclerotic sites detected / number of imaging examinations performed
Time frame: Month 1
The presence / absence of tight stenosis on the supra aortic arteries
Time frame: Month 1
The presence / absence of an occlusion on the supra aortic arteries
Time frame: Month 1
The presence / absence of a dissection on the supra aortic arteries
Time frame: Month 1
The number of atherosclerotic lesions in the aortic arch
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of crevices
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses
Time frame: Month 1
Detection of patent foramen ovale (yes/no)
Time frame: Month 1
Presence / absence of a thrombus or a circulatory stasis in the left atrium
Time frame: Month 1
Extent of atherosclerosis: affects the coronary arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the aortic valve? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the aortic arch? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the abdominal aorta? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the renal arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects digestive arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects supra aortic trunks? yes/no
Time frame: Month 1
For each detected incidentaloma: volume (mm^3)
Time frame: Month 1
The thickness of the left atrial wall
Time frame: Month 1
Presence / absence of paroxysmal atrial fibrillation
Time frame: 36 months
Presence / absence of a cardiovascular event de novo.
Time frame: 36 months
Survival (yes/no)
Time frame: 12 months
Survival (yes/no)
Time frame: 36 months
EQ-5D-5L questionnaire
Time frame: 12 months
EQ-5D-5L questionnaire
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
Francesco Macri, MD study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Imaging Assessment and LDWBA first (CT scan) in people with Stroke and Ischemic Attack, Transient, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Macri, MD (+33.(0)6.19.42.18.52, francesco.macri@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of at least one element requiring specific treatment (time frame: Day 30). It is what the study was designed to measure, not a finding.
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 Mar 2025.