Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803838
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-26
First Post:
2018-09-10
Brief Title:
The Gut and Oral Bacteria Atherosclerosis and Ischemic Stroke Study
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
The Gut and Oral Bacteria Atherosclerosis and Ischemic Stroke Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke
The investigators aim to show that these metabolite levels are diet-dependent mainly egg yalk and red meat and associated with specific types of microbiota
The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis
The investigators aim to show that these metabolite levels are diet-dependent mainly egg yalk and red meat and associated with specific types of microbiota
The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis
Detailed Description:
The Project will include four studies
Study 1 Comparative cross-sectional study The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls
This study will be done on prospectively collected information already available in our existing database Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis verified by ultrasound cardiovascular outcome defined as strokeTIA or vascular death as well as traditional risk factors for ischemic stroke diabetes hypertension smoking and coronary artery disease
Study 2 Comparative cross-sectional study The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet in particular Rich in red meat and egg yalk
In this study 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIAstroke will be compared to 70 controls Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by Lipidklinikken Rikshospitalet Feces saliva and blood will be collected analyzed for microbiota and metabolites Antroprometrics blood pressure and pulse will be recorded
In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done
Study 3 Comparative cross-sectional study The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood as well as known risk factors for stroke and inflammation on imaging modalities ultrasound 3-T MRI and PETCT
In this study 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIAstroke will be compared to 70 controls
Patients will undergo investigations with carotid ultrasound carotid and cerebral MR imaging blood tests including inflammatory biomarkers A sub-group of patients will in addition undergo PETCT imaging of carotid arteries
Study 4 Follow up study The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis
Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations Findings with serum levels of microbiota metabolites traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression
Study 1 Comparative cross-sectional study The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls
This study will be done on prospectively collected information already available in our existing database Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis verified by ultrasound cardiovascular outcome defined as strokeTIA or vascular death as well as traditional risk factors for ischemic stroke diabetes hypertension smoking and coronary artery disease
Study 2 Comparative cross-sectional study The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet in particular Rich in red meat and egg yalk
In this study 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIAstroke will be compared to 70 controls Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by Lipidklinikken Rikshospitalet Feces saliva and blood will be collected analyzed for microbiota and metabolites Antroprometrics blood pressure and pulse will be recorded
In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done
Study 3 Comparative cross-sectional study The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood as well as known risk factors for stroke and inflammation on imaging modalities ultrasound 3-T MRI and PETCT
In this study 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIAstroke will be compared to 70 controls
Patients will undergo investigations with carotid ultrasound carotid and cerebral MR imaging blood tests including inflammatory biomarkers A sub-group of patients will in addition undergo PETCT imaging of carotid arteries
Study 4 Follow up study The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis
Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations Findings with serum levels of microbiota metabolites traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None