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Atherosclerosis and Acute Ischemic Stroke Study

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ClinicalTrials.gov Identifier: NCT03685006
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborators:
University of Oslo
University Hospital, Akershus
Østfold Hospital Trust
Vestre Viken Hospital Trust
Information provided by (Responsible Party):
Mona Skjelland, Oslo University Hospital

Tracking Information
First Submitted Date August 10, 2018
First Posted Date September 26, 2018
Last Update Posted Date September 26, 2018
Actual Study Start Date January 1, 2009
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2018)
Plasma markers and advanced ultrasound of neck arteries to detect plaque instability, predict stroke risk and correlation to stroke aetiology. [ Time Frame: one year ]
Blood test, ultrasound, cerebral MRI, clinical assessment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 24, 2018)
  • Plasma markers to predict plaque instability [ Time Frame: At inclusion ]
    Blood test, ultrasound, cerebral MRI
  • Advanced ultrasound for detection of carotid plaque instability [ Time Frame: At inclusion and after one year ]
    Ultrasound, blood test, cerebral MRI, histology of carotid artery plaques
  • Plasma markers to determine correlation of acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source [ Time Frame: At inclusion ]
    Blood tests, ultrasound of neck arteries, cerebral MRI, histology of removed cerebral thrombi
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Atherosclerosis and Acute Ischemic Stroke Study
Official Title Carotid Atherosclerosis, Inflammation and Ischemic Stroke
Brief Summary A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. However the identification and characterization of the different inflammatory factors, as well as their relative importance, have not been clarified. This main aim of this study is to identify new risk markers for atherosclerosis and to characterize more precise methods for detection of the unstable carotid plaque with increased stroke-risk.
Detailed Description

This project include patients with asymptomatic and symptomatic carotid stenosis >50%. Patients with acute ischemic stroke will also be included with carotid artery stenosis <50% (study 3). The patient group will undergo a clinical neurological examination, ultrasound of the neck-arteries and a blood sample. The majority will also have a CT-angiography of the neck arteries and a cerebral MRI or CT. Carotid plaques removed by surgery (carotid end-arterectomy) and thrombs removed by thrombectomy will undergo histological analyses.

Study 1:

Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).

Study 2:

Results from advanced ultrasound of the carotid plaque including assessment of plaque morphology will be compared to histology of the removed plaque. Plasma markers and clinic will be related to the findings. The correlation between the different diagnostic modalities and the histologic conclusion will be assessed.

Study 3:

This study focus on plasma markers in an acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source. Thrombi removed from the cerebral artery by thrombectomy will undergo histological analysis and the results will be compared to plasma markers and stroke aetiology.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples Without DNA
Description:
Carotid artery plaques removed by carotid endartrectomy Plasma
Sampling Method Probability Sample
Study Population Patients with carotid atherosclerosis and/ or cerebrovascular symptoms/ disease.
Condition
  • Atherosclerosis
  • Inflammation
  • Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 24, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with an atherosclerotic carotid stenosis >50% admitting one of the study centres as an in-patient or an out-patient will be considered for inclusion.
  • Acute stroke patients treated with thrombectomy at Oslo University Hospital will be included even though the carotid stenosis is < 50%.

Exclusion Criteria:

  • Malign disease
  • Inflammatory disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mona Skjelland, MD/ postdoc +47 23073593 moskje@ous-hf.no
Contact: Karolina Skagen, MD/postdoc +4723070000 kskagen@ous-hf.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03685006
Other Study ID Numbers REK 2009/5237
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mona Skjelland, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • University of Oslo
  • University Hospital, Akershus
  • Østfold Hospital Trust
  • Vestre Viken Hospital Trust
Investigators
Principal Investigator: Mona Skjelland, MD/postdoc Oslo University Hospital, Oslo, Norway
PRS Account Oslo University Hospital
Verification Date September 2018