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
|Condition or disease|
|Atherosclerosis Inflammation Ischemic Stroke|
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.
Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).
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.
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]|
|Estimated Enrollment :||500 participants|
|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|
- 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
- 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
Biospecimen Retention: Samples Without DNA
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
|Contact: Mona Skjelland, MD/ postdoc||+47 email@example.com|
|Contact: Karolina Skagen, MDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Contact: Mona Skjelland, MD/Postdoc +4723073593 email@example.com|
|Principal Investigator:||Mona Skjelland, MD/postdoc||Oslo University Hospital, Oslo, Norway|