Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorCentre Hospitalier Universitaire de Nīmes

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine Imaging Assessment

    Other intervention

    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.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Routine ImagingActive comparator 1 intervention
Group B: LDWBA firstExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 30

Secondary outcomes

1

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.

Time frame
between day 1 and hospital discharge (expected maximum of two weeks)
2

Length of hospital stay (h)

The units are given in hours even for long stays.

Time frame
hospital discharge (expected maximum of two weeks)
3

Patient pathway: the number of imaging exams required

Time frame
Month 1
4

Patient pathway: the types of imaging exams required

Time frame
Month 1

Other outcomes

Sponsors and contacts

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