Atrial Fibrillation, Intracardiac Thrombus
Conditions
Keywords
Atrial Fibrillation, Intracardiac Thrombus, Anticoagulation Therapy, Major adverse cardiovascular and cerebrovascular events
Brief summary
This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus. Additionally, the study aims to analyze factors that influence the responsiveness and occurrence of adverse events related to anticoagulant therapy.
Detailed description
The researcher-initiated clinical cohort study is a national multicenter, retrospective-prospective study of non-valvular atrial fibrillation patients with intracardiac thrombus, based on molecular biology and multi-omics analysis. The study aims to analyze the changes in the body's immune status, metabolic status, and host microbiome community structure, as well as to analyze the factors that influence the responsiveness of intracardiac thrombus to anticoagulant therapy. The study also evaluates the occurrence of adverse events related to anticoagulation in these patients.
Interventions
Observational; No Interventions were given.
Sponsors
521 Hospital of NORINCO Group
Shaanxi Provincial People's Hospital
Xiangyang Central Hospital
Henan Provincial People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old, age ≤80 years old * Patients with atrial fibrillation detected by routine surface 12-lead electrocardiography or Holter * Transesophageal echocardiography confirmed the presence of cardiac thrombus, and the patient had not received any anticoagulant therapy
Exclusion criteria
* Echocardiography confirmed valvular heart disease * Contraindications to anticoagulants * Patients with the previous history of hemorrhagic stroke * Low platelet count or functional platelet defects * Congenital or acquired coagulation or bleeding disorders * Abnormal liver function (liver enzymes \>2 times the upper limit) * Renal failure (endogenous creatinine clearance \<30ml/min) * Surgery was planned within the intended study time or had been operated within 30 days before the study * Other comorbidities that can cause bleeding, such as tumors * Patients with autoimmune diseases or immunodeficiency, or patients who are currently using immunosuppressants and immunomodulators * Patients are currently participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of thrombolysis | 1，2，3 months after enrollment. | Success rate of thrombolysis within 3 months after initiating anticoagulation therapy. |
| Change of incidence of MACCE | 1，2，3 months after enrollment. | Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of incidence of myocardial infarction | 1，2，3 months after enrollment. | Myocardial infarction diagnosed by clinical doctors. |
| Change of incidence of adverse anticoagulation events | 1，2，3 months after enrollment. | Bleeding and thrombotic events |
| Change of incidence of stroke | 1，2，3 months after enrollment. | Stroke diagnosed by clinical doctors. |
| Change of incidence of coronary revascularization | 1，2，3 months after enrollment. | Coronary revascularization assessed by clinical doctors. |
| Change of incidence of all-cause mortality | 1，2，3 months after enrollment. | All-cause mortality diagnosed by clinical doctors. |
Countries
China
Contacts
Primary ContactGuoliang Li
Backup ContactChaofeng Sun
Outcome results
None listed