Atrial Fibrillation Clinical Trial
— RALiCOfficial title:
Stratifying Clinical Risk in Patients With Atrial Fibrillation and Chronic Kidney Disease by Studying How Abnormalities in Clot Structure/Function and Lipoproteins Contribute to Thrombosis and Bleeding
Verified date | August 2022 |
Source | University of Liverpool |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation
Status | Terminated |
Enrollment | 56 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 6.1 Inclusion criteria WP1: - On anticoagulation therapy - Informed consent obtained WP2: - Not receiving statins prior to recruitment - Diagnosed atrial fibrillation - On anticoagulation therapy - Estimated glomerular filtration rate of <50 ml/min/1.73m2 - Informed consent obtained 6.2 Exclusion criteria - Age <18 years - Severe mitral stenosis or presence of metallic prosthetic valve - Active or recent malignancy (<6 months) - Active immunological disease - Connective tissue disease - Chronic liver disease - Recent or chronic serious infection - Chronic inflammatory disease - Known haemophilia or thrombophilia - Active bleeding - Untreated hypothyroidism or hyperthyroidism - Recent surgery (<3 months) - Familial lipid disorders - Concurrent use of steroids - Dietary supplements known to influence lipids - Contraindications/inability/unwillingness to commence statin (WP2) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool Heart and Chest Hospital | Liverpool | |
United Kingdom | Liverpool University Hospitals NHS Foundation Trust | Liverpool |
Lead Sponsor | Collaborator |
---|---|
University of Liverpool | Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool John Moores University, University of Leeds |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test | Lag time, maximum absorbance, time to maximum absorbance and clot lysis time | At baseline | |
Primary | WP1: Fibrin permeation analysis using validated test | Permeation constant (Ks) | At baseline | |
Primary | WP1: Low density lipoprotein fractions | Measure of low density lipoprotein subclass fractions | At baseline | |
Primary | WP1: Oxidised low density lipoprotein | Measure of oxidised low density lipoprotein | At baseline | |
Primary | WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test | Lag time, maximum absorbance, time to maximum absorbance and clot lysis time | At baseline and after 6 weeks of statin therapy | |
Primary | WP2: Fibrin permeation analysis using validated test | Permeation constant (Ks) | At baseline and after 6 weeks of statin | |
Primary | WP2: Low density lipoprotein fractions | Measure of low density lipoprotein subclass fractions | At baseline and after 6 weeks of statin | |
Primary | WP2: Oxidised low density lipoprotein | Measure of oxidised low density lipoprotein | At baseline and after 6 weeks of statin | |
Secondary | WP1: Scanning electron microscopy | Qualitative assessment of fibril indices | At baseline |
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