Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atherosclerosis and Acute Ischemic Stroke Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease
Atherosclerosis Inflammation Ischemic Stroke

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Carotid Atherosclerosis, Inflammation and Ischemic Stroke
Actual Study Start Date : January 1, 2009
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Plasma markers to predict plaque instability [ Time Frame: At inclusion ]
    Blood test, ultrasound, cerebral MRI

  2. 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

  3. 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


Biospecimen Retention:   Samples Without DNA
Carotid artery plaques removed by carotid endartrectomy Plasma


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with carotid atherosclerosis and/ or cerebrovascular symptoms/ disease.
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

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): NCT03685006


Contacts
Layout table for location contacts
Contact: Mona Skjelland, MD/ postdoc +47 23073593 moskje@ous-hf.no
Contact: Karolina Skagen, MD/postdoc +4723070000 kskagen@ous-hf.no

Locations
Layout table for location information
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Mona Skjelland, MD/Postdoc    +4723073593    moskje@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
University Hospital, Akershus
Østfold Hospital Trust
Vestre Viken Hospital Trust
Investigators
Layout table for investigator information
Principal Investigator: Mona Skjelland, MD/postdoc Oslo University Hospital, Oslo, Norway

Additional Information:

Layout table for additonal information
Responsible Party: Mona Skjelland, Consultant, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03685006     History of Changes
Other Study ID Numbers: REK 2009/5237
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Inflammation
Ischemia
Cerebral Infarction
Atherosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Arteriosclerosis
Arterial Occlusive Diseases