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Not yet recruiting NCT06141538

Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)

— Observational Atrial Fibrillation Intracardiac Thrombus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational; No Interventions were given..
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Intracardiac Thrombus. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Observational Cohort Study

Overview

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

  • Other Observational; No Interventions were given.
    Observational; No Interventions were given.

Primary outcome measures

  • Success rate of thrombolysis [Time frame: 1，2，3 months after enrollment.]
  • Change of incidence of MACCE [Time frame: 1，2，3 months after enrollment.]
Secondary outcome measures (5)
  • Change of incidence of adverse anticoagulation events [Time frame: 1，2，3 months after enrollment.]
  • Change of incidence of all-cause mortality [Time frame: 1，2，3 months after enrollment.]
  • Change of incidence of myocardial infarction [Time frame: 1，2，3 months after enrollment.]
  • Change of incidence of coronary revascularization [Time frame: 1，2，3 months after enrollment.]
  • Change of incidence of stroke [Time frame: 1，2，3 months after enrollment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Xian Jiantong University — Xi'an

Identifiers

NCT: NCT06141538 · XJTU1AF2023LSK-404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗