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NCT Number: NCT02662751

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

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Montpellier - Hôpital Gui de Chauliac, Montpellier, France

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About this study

The secondary objectives are:

A. To compare the patient pathways between the two arms in terms of time to diagnosis, and duration of hospitalization.

B. To compare the consumption of imaging exams (number and type) and total body irradiation between the two arms.

C. To compare the diagnostic efficiency between the two arms in terms of detection of predefined lesions, and performance ratios.

D. To study the thickness of the left atrial wall as a risk factor for permanent atrial fibrillation.

E. To compare the distribution of suspected neoplasms between the two groups, as well as the number of detected incidentalomas.

F. To compare the survival and the incidence of new cardiovascular events between the two arms at 12 months and 36 months.

G. To compare the quality of life between the two arms at 12 months and 36 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Routine Imaging Assessment

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Diagnostic delay (h)

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

    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.

  2. Length of hospital stay (h)

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

    The units are given in hours even for long stays.

  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

  5. Total irradiation (mSv) during patient pathway

    Time frame: Month 1

  6. For contrast injections during the patient pathway: total grams of iodine injected

    Time frame: Month 1

  7. Number of atherosclerotic sites detected / number of imaging examinations performed

    Time frame: Month 1

  8. The presence / absence of tight stenosis on the supra aortic arteries

    Time frame: Month 1

  9. The presence / absence of an occlusion on the supra aortic arteries

    Time frame: Month 1

  10. The presence / absence of a dissection on the supra aortic arteries

    Time frame: Month 1

  11. The number of atherosclerotic lesions in the aortic arch

    Time frame: Month 1

  12. For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)

    Time frame: Month 1

  13. For each atherosclerotic lesion in the aortic arch: presence/absence of crevices

    Time frame: Month 1

  14. For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses

    Time frame: Month 1

  15. Detection of patent foramen ovale (yes/no)

    Time frame: Month 1

  16. Presence / absence of a thrombus or a circulatory stasis in the left atrium

    Time frame: Month 1

  17. Extent of atherosclerosis: affects the coronary arteries? yes/no

    Time frame: Month 1

  18. Extent of atherosclerosis: affects the aortic valve? yes/no

    Time frame: Month 1

  19. Extent of atherosclerosis: affects the aortic arch? yes/no

    Time frame: Month 1

  20. Extent of atherosclerosis: affects the abdominal aorta? yes/no

    Time frame: Month 1

  21. Extent of atherosclerosis: affects the renal arteries? yes/no

    Time frame: Month 1

  22. Extent of atherosclerosis: affects digestive arteries? yes/no

    Time frame: Month 1

  23. Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no

    Time frame: Month 1

  24. Extent of atherosclerosis: affects supra aortic trunks? yes/no

    Time frame: Month 1

  25. For each detected incidentaloma: volume (mm^3)

    Time frame: Month 1

  26. The thickness of the left atrial wall

    Time frame: Month 1

  27. Presence / absence of paroxysmal atrial fibrillation

    Time frame: 36 months

  28. Presence / absence of a cardiovascular event de novo.

    Time frame: 36 months

    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)

  29. Survival (yes/no)

    Time frame: 12 months

  30. Survival (yes/no)

    Time frame: 36 months

  31. EQ-5D-5L questionnaire

    Time frame: 12 months

  32. EQ-5D-5L questionnaire

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Carey Suehs, PhD

CONTACT

[email protected]

+33.(0)4.66.68.67.88

Francesco Macri, MD

CONTACT

[email protected]

+33.(0)6.19.42.18.52

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: VASCU

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2016
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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