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

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ClinicalTrials.gov Identifier: NCT02662751
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Ischemic Attack, Transient Other: Routine Imaging Assessment Device: LDWBA first (CT scan) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine Imaging

Patients randomized to this arm will have routine post-stroke/TIA imaging assessments.

Intervention: Routine Imaging Assessment

Other: Routine Imaging Assessment

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.


Experimental: LDWBA first

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.

Other: Routine Imaging Assessment

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.


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.

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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662751


Contacts
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Contact: Francesco Macri, MD +33.(0)6.19.42.18.52 francesco.macri@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
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France
CHRU de Montpellier - Hôpital Gui de Chauliac Recruiting
Montpellier Cedex 5, France, 34295
Principal Investigator: Alain Bonafe, MD, PhD         
Sub-Investigator: Vincent Costalat, MD         
Sub-Investigator: Nicolas Menjot de Champfleur, MD         
CHRU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 09, France, 30029
Sub-Investigator: Francesco Macri, MD         
Principal Investigator: Jean Paul Beregi, MD, PhD         
Sub-Investigator: Cornelia Freitag, MD         
Sub-Investigator: Liliane Metge, MD         
Sub-Investigator: Xavier Stefanovic, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Francesco Macri, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02662751    
Other Study ID Numbers: AOI/2014/FM-01
2015-A01600-49 ( Other Identifier: RCB number )
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia